To ensure the safety of medical devices, the U.S. Food and Drug Administration (FDA) has put a number of regulations and requirements into place. Companies that manufacture medical devices must comply with these regulations, which can be complex and time-consuming. This blog post will provide an overview of the FDA’s regulatory framework for medical devices and discuss some key compliance considerations. 

We hope the below information will help you to understand the FDA’s requirements and make informed decisions about your product development strategy.

Medical Device Requirements

The old FDA medical device regulations in the United States were implemented in the late 1970s, and remained unchanged today. Medical technology has advanced rapidly in the intervening years, and the medical device industry has become increasingly globalized. As a result, the old regulations are no longer adequate to protect patients and ensure the safety of medical devices. The FDA is continually revising the medical device regulations, and the new regulations were released in 2019. 

The new regulations are more comprehensive and take into account the latest medical technology. They are also more flexible, allowing for different types of medical devices to be approved for use in the United States.

COVID 19’s Impact on Medical Device Regulations

In the wake of the COVID-19 pandemic, the FDA has significantly changed its approach to medical device regulations. Recognizing the critical role medical devices play in medical outcomes and public health, the agency has prioritized expediting and streamlining review processes for new medical devices. This includes opening up new pathways for medical device contract manufacturing developers to pursue approval and reviewing existing medical devices for possible updates or revisions to their regulatory status. 

Furthermore, the FDA is also working closely with other regulatory bodies from around the world to help ensure that medical devices are being evaluated and approved using rigorous standards and best practices. 

Through these efforts, the FDA hopes to promote innovation in medical device technology while also ensuring that patients are protected from potential risks associated with these cutting-edge technologies.

By 2022, the FDA released several new medical device regulations that manufacturers must comply with. These include new requirements for clinical trial data, post-market surveillance, and labeling. 

In addition, the FDA has revised its guidance on medical device modifications and has issued new guidance on the 3D printing of medical devices. Manufacturers who fail to comply with these regulations may face significant penalties, including fines and product recalls.

Medical Device Requirements and Classifications

Medical device regulations for contract medical manufacturing are becoming increasingly important in the United States. These regulations describe the classification of medical devices based on their level of risk and determine the extent of oversight required when developing and marketing these devices. Medical device regulations can be grouped into three main categories: class I, class II, and III.

Class I medical devices generally require less scrutiny than those in classes II or III. They include simple medical products such as bandages, compression stockings, and pairs of eyeglasses. Class II medical devices are typically more complex in nature and include medical products such as insulin pumps, hearing aids, and pacemakers. Finally, class III medical devices tend to be high-risk products that require a significant amount of regulatory oversight due to their complexity or potential for serious harm to patients if misused. Examples of class III medical devices include artificial organs or advanced surgical equipment.

With increasing complexity in the medical field, we must continue to develop robust medical device regulations that adequately protect patients while encouraging innovation. As we move through 2022 and beyond, it will be interesting to see how these regulations evolve and their impact on the healthcare industry as a whole.

U.S. medical device regulations are demanding, with rigorous safety standards. The medical device industry has to follow some strict guidelines that ensure patient protection and public accountability at all times, which are:

1. Establishment Registration
2. Medical Device Listing
3. Premarket Notification 510(k) 
4. Premarket Approval
5. Investigational Device Exemption (IDE) for clinical studies
6. Quality System (QS) regulation
7. Labeling requirements
8. Medical Device Reporting (MDR)

1. Establishment Registration 

The FDA’s medical device regulations (21 CFR Part 807) require that manufacturers and initial distributors of medical devices register their establishments with the FDA, submit registration information electronically, and pay an establishment registration fee. These requirements apply to both domestic and foreign establishments. 

In addition, foreign manufacturers must also designate a U.S. agent. Establishment registration and listing provide the FDA with basic information about medical device establishments, including the types of devices manufactured at each establishment and the names and addresses of their owners or operators. This information helps the FDA to identify medical device establishments for potential inspection and notify establishments of recalls and other important announcements. 

The FDA verifies medical device establishment registration information annually between October 1st and December 31st of each year. Most establishments are required to pay an establishment registration fee beginning October 1, 2007.

 2. Medical Device Listing

Medical device listing refers to the regulation outlined in 21CFR Part 807. This outlines the requirements for medical device manufacturers to ensure that their products are safe and effective. These regulations apply to a wide range of medical devices, including everything from drug delivery systems and surgical instruments, to laboratory equipment and medical diagnostic tools. 

In order to comply with the medical device listing requirements outlined in this regulation, manufacturers must submit detailed information about their products to the FDA, including their intended uses, manufacturing processes, sterility status, packaging designs, testing methods, performance data, and any known health risks or contraindications associated with each device. 

Additionally, medical device labeling must be clear and easy to understand in order to ensure that healthcare professionals and patients can make informed decisions about whether or not to use these products. Overall, medical device listing is essential for ensuring the safety and efficacy of medical devices in today’s healthcare landscape.

 3. Premarket Notification 510(k)

Premarket Notification 510(k) is a medical device regulatory program that was developed by the U.S. Food and Drug Administration to ensure the safety, efficacy, and quality of medical devices. This program applies to all medical devices that are intended for use in the diagnosis, prevention, or treatment of illness or conditions. In order to file a Premarket Notification 510(k) with the FDA, manufacturers must first demonstrate that their medical device is either substantially equivalent to another medical device on the market or that their medical device offers some significant new benefit. This process typically involves an intensive review of detailed technical specifications, and testing data and extensive documentation of the potential risks and benefits. 

While the specific tests that are performed may vary depending on the device in question, some commonly used examples include functional performance testing, safety, and efficacy testing, biocompatibility testing, and microbiological studies. Additionally, medical professionals may also need to evaluate medical instruments based on design calculations or mathematical models, along with various types of imaging studies. Through these multiple types of premarket testing, medical device manufacturers can ensure that their products are safe and effective for clinical use.

Overall, Premarket Notification 510(k) is vital for ensuring that medical devices used in patient care are safe and effective.

 4. Premarket Approval

Premarket approval (PMA) is the FDA regulatory process for medical devices that are intended to support or sustain human life, be implanted in the human body, or present a potential, unreasonable risk of illness or injury. 

A medical device manufacturer wishing to market a device in the United States must submit a PMA application to the FDA and receive FDA approval before selling the device. The FDA’s decision to approve or deny a PMA application is based on a review of data that demonstrates that the device is safe and effective for its intended use. The FDA may also require post-marketing studies to be conducted after a device is approved further to assess its safety and effectiveness of the device.

5. Investigational Device Exemption (IDE)

Investigational Device Exemption (IDE) is a mechanism medical device manufacturers use to conduct clinical studies on new medical devices legally. This process is vital because it allows medical device companies to gather data on the safety and effectiveness of their products before bringing them to market. 

In order to receive an IDE, medical device companies must submit detailed information about their proposed studies, including the study protocol and design, as well as a complete description of their medical device. They must also demonstrate that their medical device is safe for human use and provide evidence that its potential benefits outweigh the risks associated with using the product. As such, obtaining an investigational device exemption is critical for medical device companies seeking to bring new products to market. Ultimately, this process helps ensure that medical devices are safe and effective before they can be made available to patients.

6. Quality System (QS) Regulation

Quality system (QS) regulation is a set of international medical device regulatory standards that apply to medical device manufacturers. This regulation was established by the International Organization for Standardization (ISO) and aimed to ensure medical devices are safe, effective, and reliable. At its core, QS regulation requires medical device manufacturers establish systems and processes that meet specific quality standards throughout the development and production of their products. These standards require that medical devices be tested and evaluated for quality, performance, safety, and other factors before being approved for distribution.

As the use of medical devices continues to rise around the world, it has become more critical than ever for regulatory authorities to enforce strict QS regulations in order to protect patients from dangerous or faulty medical devices. In addition, this can help ensure that medical products on the market are consistently high-quality and reliable, allowing patients to receive the treatment they need without undue risk. Ultimately, QS regulation benefits both medical providers and patients by facilitating the development of safe and effective medical devices.

7. Labeling Requirements

Labels are an essential part of medical devices, as they provide crucial information about the products that people use to manage their health. However, the regulatory requirements for medical device labeling can vary depending on many factors, including the type and classification of the device and whether or not the FDA has approved it. For example, manufacturers must often include detailed information about product risks and side effects and detailed instructions on how to use the device safely. 

Additionally, medical devices may also need to be labeled in multiple languages depending on where they are used.

Overall, the labeling requirements for medical devices play an essential role in safeguarding patients’ health and safety. Ensuring that medical products are clearly labeled with the appropriate information can help prevent adverse events and serious injuries related to improper or inaccurate use. And by making medical labels accessible to people of all backgrounds and abilities, we can increase access to quality healthcare.

8. Medical Device Reporting (MDR)

Medical device reporting (MDR) is a regulatory requirement for medical device manufacturers. It requires that manufacturers report any incidents where their medical devices may have caused or contributed to patient death or serious injury. In addition, manufacturers must report any incidents where their medical devices may have malfunctioned in a way that could result in patient harm.

MDR reporting is essential because it helps to improve the safety of medical devices. By requiring manufacturers to report incidents, the FDA can identify patterns of problems with specific devices. This information can then be used to develop new safety standards or requirements, which can help to prevent future incidents from occurring.

In addition, MDR reporting helps ensure that medical device manufacturers are held accountable for the safety of their products. By publicly disclosing incidents, manufacturers are more likely to take steps to prevent similar problems from occurring in the future. This can help to improve the overall safety of medical devices on the market.

HDA’s Medical Devices Regulatory Method 

As one of California’s top medical manufacturing companies, at HDA Technology we are committed to providing medical professionals with innovative and high-quality medical devices that meet the rigorous regulatory standards of the United States. Our products are FDA and FDB registered, which means they have been carefully reviewed and tested according to strict standards. This assures providers that our medical devices, including portable imaging equipment, surgical tools, and patient monitoring systems, are safe and reliable. By partnering with HDA Technology, medical professionals can be confident that they provide their patients with the best care possible. 

As a medical device manufacturer, we have a robust quality management system to meet the stringent regulatory requirements of ISO certifications. Therefore, our rigorous quality management system has been designed to ensure that our products meet all required regulatory standards, including ISO 13485 certification. This is a critical certification, as it indicates that HDA’s medical devices have been thoroughly tested and evaluated to ensure the highest quality, safety, and effectiveness.

Given the importance of medical device regulations in ensuring patient safety, medical device companies must be held to the strictest standards by regulatory bodies like ISO 13485. 

At HDA, we have implemented a rigorous QMS that is fully compliant with all industry regulations and standards. In addition, our team of expert engineers has extensive experience managing medical device manufacturing processes and can help ensure that your product is manufactured safely and efficiently. 

HDA Supports 501(k) Filing and Clinical Testing

When faced with the need to produce medical devices for clinical testing or FDA approval, companies often turn to contract manufacturing services like those offered here at HDA. With our Compliant Pilot Production service, you can get your products to market faster and mitigate the risk of delays or compliance failures. 

Compliant pilot production of medical devices is a term used to describe the process of producing medical devices in accordance with all applicable medical device requirements. In order to ensure compliance, medical device manufacturers must have a thorough understanding of all relevant medical device requirements, including those relating to design, manufacturing, labeling, and quality. They must also have the ability to communicate these requirements to their suppliers and other stakeholders effectively. By working with experienced medical device compliance consultants like ours, manufacturers can ensure that their pilot production activities are compliant with all applicable medical device requirements.

Whether you are looking for cutting-edge imaging technologies or reliable monitoring systems, HDA has the products you need to stay at the forefront of your field. By choosing HDA for your medical device needs, you can trust that you are getting a medical device that has been rigorously tested and evaluated for safety, efficacy, and overall quality.
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HDA Technology is a medical device assembly company specializing in the manufacture and assembly of custom medical devices. Our manufacturing services cater specifically to the medical device and IVD industries. With over 40 years of experience, we are experts in the field and can provide you with high-quality products that meet your specific needs. 

Our team of experts is equipped with the latest technology and equipment to handle your most challenging projects. From design and prototyping to full-scale production services for medical equipment, HDA Technology can help you take your product from concept to reality. 

The Contract Medical Manufacturing Process

A company seeking a third party for their medical device assembly may not know what the process entails as a whole. Contract medical manufacturing encompasses the contracting out of the design, development, and production of medical devices to third-party companies. 

This type of manufacturing is often used by small or startup businesses that do not have the resources to develop and manufacture their products. Contract medical manufacturing is also used regularly by larger companies that want to outsource some or all of their production. There are many benefits to contract medical manufacturing, including cost savings, increased efficiency, and access to specialized expertise.

Contract medical manufacturing involves different steps depending on the product being manufactured. In general, contract medical manufacturers will first create a device prototype. Once the prototype is approved, the manufacturer will create a production mold and begin mass-producing the device. Finally, the manufacturer will assemble and test the finished product before shipping it to the customer. 

This is the process at its most simple; but the right partners and vendors can assist with smoothing out unforseen bumps. Contract medical manufacturers offer a wide range of services, from simple assembly to complete product development. As a result, businesses can choose the level of involvement that best suits their needs.

What Sets HDA Technology Apart

HDA Technology delivers cost-effective and reliable results for your product manufacturing process. We have expertise in sourcing BOMs, developing the necessary procedures to meet high volumes with low inventory requirements, as well as in handling large orders that vary based on demand patterns — like you need them to!

Our lean practices allow us to optimize our facilities quickly. Hence, they match what’s needed by any one particular client — no matter how much production varies within the different products being made by an individual company at any given time. As a result, HDA’s lean manufacturing process offers you and your company many benefits, such as decreased lead time. In addition, our reconfigurable services allow us the flexibility of creating products on demand so they can be shipped out quicker than ever before!

Our Medical Equipment Assembly Services

HDA is committed to providing you with the most cost-effective production options. By sourcing only what we need for our products and optimizing how they are made, HDA ensures your costs stay low without sacrificing quality!

We pride ourselves on being a full-service production team that can turn your idea into reality. Our experienced and knowledgeable staff will work hard to ensure high-quality products for you every time/

We incorporate streamlined manufacturing, eliminating waste and inefficiencies to get products out the door quickly and safely. Our priority is a combination of speed with safety — always first for a reason!

By partnering with us, you will reduce lead times by eliminating unnecessary processes during development so you can focus on what matters most: creating innovative solutions that will innovate your industry forever.

HDA can match your order size . . . no matter how big it gets. We provide fast turnaround on high-volume orders because of our efficient production practices, which allow us to comfortably scale up at mass volumes without sacrificing quality or reliability.

HDA Production And Certification

If you’re looking for a cost-effective contract manufacturing solution to support your 510(k) filing or clinical testing, HDA is here to help. We specialize in compliant pilot production, and our FDA-certified production facility can produce fully compliant orders quickly and efficiently. This will help you mitigate compliance delays and failures and get your product to market faster. 

In addition to medical equipment assembly, we offer a wide range of services to support your project, including purchasing and BOM management. Other services include:

• Compliant clinical unit production
• Prototype production
• Volume production
• Box build
• System build
• Disposables
• Optical
• Radio frequency
• Calibration
• Test
• After-sale support

At HDA Technology, we are proud to be a registered and certified medical device manufacturer. As a full-service medical product development and manufacturing company, we have years of experience supporting medical professionals and their development of a wide range of products and services. Our dedicated team has been specially trained in the designing, testing, and assembling of medical devices ranging from diagnostic equipment to orthopedic implants. 

Drawing on our deep knowledge of medical standards and practices, we ensure that our products meet or exceed all FDA and FDB requirements. Additionally, we are committed to maintaining the highest standards for quality control using the latest ISO procedures. Whether you are just starting or your medical business is well established, our team at HDA Technology is here to help support your growth and success. So if you’re looking for experienced medical professionals who can provide top-quality device assembly and manufacturing services, look no further than HDA Technology!

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There are only a handful of companies that can do what we do. HDA Technology (HDA) has the experience and ability to take your medical device product from concept to shipping. Our decades of experience in medical device manufacturing uniquely positions us as an industry-leading, full-service medical device developer.

HDA provides full development and manufacturing services to companies ranging from medical startups to multinational healthcare corporations. Our FDA-registered facility specializes in developing and manufacturing Class I, II, and III medical devices. And we have a track record of success on even the most technical challenges. HDA can help your company navigate the complexities of prototype development and testing, and scale manufacturing to meet your production goals.

HDA has the expertise and know-how to guide your company through the complete lifecycle of your medical device product. We support our customers with a robust, expert product development team that quickly and competently moves each product through each stage of the process:

• Device Design Controls
• Proof of Concept Prototyping
• Pre-compliance Evaluation & Testing
• Device Design & Engineering Support
• Lab Testing & Verification
• Manufacturing Plan and Processes
• Volume Manufacturing
• Post-Market Support and Service

Our commitment to advancing medical device manufacturing with quality, safe products has made HDA one of the leading medical device development companies in Southern California. Partner with us to turn your medical device concept into reality.

Develop Your Concept

HDA Has Developed Consistent, Effective Design Controls for Medical Devices

The FDA strictly enforces regulations that reduce the likelihood of medical devices and healthcare-related harming consumers. Additionally, their quality system regulation requires medical device manufacturers to establish and adhere to controls through the development process.

Our development team streamlines product development and regulatory certification by implementing efficient, quality-preserving design controls. These design controls inform our processes throughout the development and manufacturing of your product, guaranteeing that the finished product is safe and effective.

As an ISO13485, FDA, and FDB-certified medical device manufacturer, HDA has helped countless companies meet FDA design control standards. By placing the needs of the user first, HDA guarantees that the product is FDA-compliant: 

• What are the needs of the user?
• Does the device meet the user’s needs?
• Does the device present any safety concerns?

Failing to address these questions can lead to significant setbacks in product development. Through years of hands-on experience in product development, HDA has developed a proven process for successful validation.

HDA Documents Development Step-by-Step

We focus on forming device design controls early in the development process to mitigate challenges in the later stages of production. Evidence-supported development and strategies inform the unique design specifications of a medical device product.

HDA uses medical device design controls to create a design history file (DHF) for your product. In addition, we maintain comprehensive documentation that confirms the functional, technical, and regulatory requirements of the design and development, and manufacturing processes to produce the product consistently.

Our thorough documentation includes a product-specific DHF which tracks the design controls process and product development:

• Design and Development Process

 We create and include a unique design plan for your product. The design plan reflects the standard and procedures of our established design controls. 

• Design Input

We develop and include procedures that outline the intended function or use of the medical device. The user’s needs are highlighted to provide a critical function and design goal for the finished product. 

• Design Output

We define and document procedures for determining design output compliance with the design input requirements. The design output procedure contains acceptance criteria that prove the proper functioning and effectiveness of the product.

• Design Process

We develop and include a procedure for reviewing the design process to confirm thoroughly conducting the reviews.

• Design Verification

We develop and include our verification and testing process throughout the product’s development. 

• Design Validation

We develop and include a procedure that defines the testing conditions and criteria used to validate the product design. The results of the validation process are also included to support DHF further.

• Design Production Transfer

We develop and include documentation on the product specifications as they comply with design controls and FDA standards. The documentation consists of procedures necessary to transfer the product to production.

• Design Changes

We document and include design changes as they occur throughout the development of the product. These changes reflect our adherence to the established design controls and support the conventional effect of your medical device.

HDA optimizes the development process by establishing crucial standards and procedures to reproduce your device’s specifications and critical functions. Our strict adherence to design controls results in high-quality products and swift regulatory certification.

At HDA, device design controls are essential for verification and validation processes. Both processes are distinctly different and crucial to ensuring that a product is safe, effective, and regulatory sufficient.

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HDA Verification Guarantees Consistent, Effective Products

Our verification process is structured to ensure that the design of your medical device meets its established requirements for safety and effectiveness. Verification is all about testing that our design outputs match our design inputs.

HDA actively verifies that design outputs meet the established design controls throughout the development process. Identifying discrepancies between the device design and management is crucial to correcting production issues before making it into the later stages of development.

Led by expert medical device design engineers, our verification process can test prototypes, systems, sub-systems, components, raw materials, and software for issues that don’t satisfy the design controls. 

By utilizing the design controls as a guiding template, HDA practices design verification to test:

• Design Requirements

Remember, design output should be design input. HDA tests the design requirements themselves by the output that they create. In addition, we maintain comprehensive design and process documentation to determine them quickly. 

• Design Process

Verification isn’t exclusive to any single level of development. Instead, we utilize verification processes to test and highlight issues within the design process itself. 

• Device Design

HDA tests to make sure that design outputs match the specifications of our design requirements. This determines if the product is on track and matches its predetermined specifications and functions.

HDA manages development and manufacturing with verification and validation processes to produce high-quality products. Both employ testing methods and standards but are performed at different stages in development.

Unlike our active verification process throughout development, validation is performed at the end. HDA leverages this dual system of testing to confirm the validity of the product and production process and guarantee the medical device is safe and effective for the user.

HDA Delivers Quality and Performance

We Simplify the Design Validation Process

All medical device products must go through validation before reaching the manufacturing process. Validation is a crucial component of the FDA certification process. Device development must consistently produce safe, effective products through design controls to meet FDA standards.

At HDA, design validation is a design controls procedure that functions as another safeguard to mitigate costly production mistakes and unsuccessful products. In addition, stringent testing measures are in place to demonstrate that the medical device functions as intended and performs as users expected it to.

Design validation is planned from the early stages of development to ensure that the end-user is always the priority during development. Validation confirms the medical device’s usability, efficacy, and safety before it heads to full-scale production.

We can produce small-batch production devices that simulate the conditions and production environment of the finished product. This is an essential detail when testing the product. We believe in removing variables and surprises by testing all processes, materials, and equipment in the development stage.

Medical device design controls help validate a product in several ways:

• Process Validation

Documenting development from design to manufacturing guarantees that the product will meet the intended specifications consistently.

• Design Validation

HDA has demonstrated over and over again that its products fulfill their intended functions and use.

HDA’s development process utilizes medical device design controls to optimize safety and production. Transparency in product development ensures that our products are helpful, non-harmful, and quickly approved in the regulatory process.

Start development on your innovative medical device design the right way. Reach out to HDA today and tell us about your revolutionary idea.

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Our Prototyping Brings Your Idea to Life

Because of our decades of experience and highly refined development process, HDA can meet your company’s needs at any stage in its development. Regardless of your unique goals, we can provide cost-effective solutions to get you there. For example, suppose you have already dedicated good design and engineering to your medical device. In that case, HDA can develop a proof of concept prototype that requires significantly less documentation than a market-ready product.

Let HDA Deliver Your Proof of Concept

Has your company identified an unfulfilled need in medical care? Have you developed an innovative product concept and need help testing the critical functions of your medical device design? HDA can test the efficacy of your idea with a proof of concept prototype.

Proof of concept prototyping offers several deliverables for your company:

• Verify Design Process. Prototyping your concept into a physical product allows us to determine whether or not the design process has achieved the intended specifications of the products. 
• Prove Functions. Similar to the verification process, prototyping makes it possible to test the functions of the products to make sure they meet the intended purposes of the design. 
• Draft Preliminary Test Methods. Prototyping allows testing the manufacturing methods and medical device design to produce an effective, consistent product.
• Design History Support. HDA provides an organized design history file that (DHF) documents your product’s design and development. We maintain DHFs for each device to make audits and inspections during the regulatory process as smooth as possible.

HDA has an extensive track record for delivering expertly-crafted prototypes and low-volume production builds to companies like yours. In addition, we can provide a cost-effective proof of concept prototype to kick off your product’s journey to the market. So get started today by telling us a little about your company and goals.

HDA’s Pre-Compliance Evaluation and Testing Saves Time and Money

Navigating the complex and intricate medical device regulatory process is not easy. Fortunately, HDA has an experienced, knowledgeable team dedicated to successfully seeing your product through the process.

HDA’s pre-compliance evaluation and testing streamlines the regulatory process and sets your product up for success. As a critical component of our product development process, pre-compliance assessment and testing ensure that you will pass certification quickly and confidently.

Benefits of Pre-Compliance Evaluation:

• Regulatory Compliance

HDA has decades of experience in the medical device industry. As a result, we understand what it takes to maintain an FDA-compliant development.

• Easy and Fast Certification

Setbacks in regulatory certifications can amount to significant delays and costly fines, possibly preventing your product from ever reaching the market. HDA mitigates certification hurdles by preparing your product for the necessary regulatory standards.

Benefits of Pre-Compliance Testing:

• Streamlined Development

We reduce the risk of lengthy delays and redesigns by testing your product’s critical functions against its intended use.

• Pre-Production Refinement

Our attentiveness to your product’s functions and use help reveal the most consistent and effective production methods. We can iron out any issues by refining the design and production process before stepping into the manufacturing stage.

HDA follows a proven process to get your medical device through development, regulatory certification, and manufacturing as efficiently as possible. Our approach is shaped by decades of experience in the medical device industry. 

Expert Medical Device Design Engineers Prepare Your Product for Manufacturing

HDA is dedicated to offering unparalleled quality and craftsmanship. We have on-site engineering support to help transform your innovative vision into a working product. In addition, our unique combination of size, experience, and wealth of resources allows us to carefully and confidently see each product through manufacturing.

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HDA is capable of manufacturing and delivering consistent, quality products that meet all necessary standards and regulations. Is your innovative medical device concept ready for production? Whether you need a limited run for clinical testing or high-volume manufacturing, HDA offers scalable options to help you achieve your production goals. 

We offer design, manufacturing, and support services to get your product into the marketplace. Our full-service development team utilizes robust manufacturing and quality management capabilities to scale expert craftsmanship and design to meet any goal. And, our in-house manufacturing floor can manufacture at any scale.

HDA presents a variety of resources and certifications that will benefit the development of your next medical device concept. In addition, our lean manufacturing process is a cost-effective solution that can deliver high-volume orders at consistent quality.

We engage in lean manufacturing to provide many benefits and advantages to our customers:

• Higher Efficiency

HDA focuses on minimizing waste within the manufacturing process while improving turnaround time and product quality. 

• Lower Production Costs

HDA saves you money by not wasting time, personnel hours, or raw materials on overproduction. 

• High-Volume Manufacturing

By reducing turnaround time through time management, more time is allotted for manufacturing your product. Additionally, the more efficient process allows manufacturing to begin and end without wasted strategies.

• Reliable and Consistent Quality

HDA is committed to providing the very best quality materials and manufacturing. Our investment in talented, expert personnel and well-performing equipment guarantees our level of quality throughout each project.

Our decades of experience have allowed us to refine our manufacturing strategies and processes. Trust HDA to manufacture your next medical device concept.

HDA is Your Medical Contract Manufacturing Company

HDA is a trusted product development partner for companies of all sizes. Our refined production processes and facilities are capable of scaling to meet high-volume manufacturing demands. We provide contract manufacturing solutions with the security of quality and cost-effective production.

Our contract manufacturing production feature essential processes and services:

• Device Design and Engineering Support

HDA has helped companies overcome logistical and technological challenges to produce their products as designed. We provide design and engineering solutions that optimize the performance of your device and streamline manufacturing and regulation processes.

• Quality Assurance

We understand the necessity for stringent quality assurance processes and protocols better than most throughout design, production, and manufacturing. Therefore, HDA adheres to strict quality standards to guarantee a safe, reliable product. 

Your project will be completed on time and within budget. HDA prioritizes thorough planning to mitigate unnecessary costs and delays throughout the development process. We operate a detail-focused development process because we know what’s at stake for your company.

• Post-Market Support and Service

Our job doesn’t end once your device makes it to market. HDA recognizes the importance of post-market monitoring and vigilance to guarantee patient safety and the future of your device. Therefore, we take a proactive approach to managing safety data to ensure the continued safety of your device.

• Calibration

Precision. Inaccurate device measurements and specifications can lead to unsafe devices, financial losses, and regulatory woes that slow down time to market. We perform instrument and device calibration to safeguard your device production against technical irregularities that may risk your device’s future.

• Purchasing and Bill of Materials (BOM)

We handle every aspect of production to offer a full-service experience for our customers. That includes procuring the raw materials necessary to complete the production of your medical device. Managing and purchasing BOM is unique for each device, so we make clear-defined material and manufacturing needs for your specific device.

HDA has experience developing and manufacturing devices with various medical applications as a leading medical device contract manufacturing company. Whether a consumer-use product or diagnostic equipment, we have tested and established production methods to efficiently and effectively manage the manufacturing process.

HDA can handle development, regulatory certification, and manufacturing for Class I, II, and III medical devices. Each class represents a device risk level; Class III is high-risk devices subject to the strictest regulatory standards. 

Our manufacturing capabilities can quickly scale to accommodate all medical device classifications and volumes. HDA’s state-of-the-art manufacturing solutions have produced successful devices that cover the spectrum of medical applications:

• Imaging and Diagnostics
• Surgical Equipment
• Radiofrequency (RF) Radiation
• Neurovascular Devices
• Airborne Emergency Oxygen Systems
• Spectrophotometry
• And more

Partner with HDA to leverage our experience and technological expertise in your groundbreaking medical device concept. We remain one of the leading medical contract manufacturing companies in Southern California because of our consistent, high-level production standards.

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Compliant Pilot Production

We offer compliant clinical prototype production to fulfill low-volume, human-use devices for clinical testing and 510(k) premarket submissions to the FDA. Our production service is operated by industry-tested engineers, technicians, and support personnel with years of experience producing successful clinical prototype builds.

HDA combines engineering-based transfer to manufacturing and procedure-based assembly to ensure that every unit meets its intended specifications before leaving our facility. In addition, we utilize product-specific test processes that evaluate and verify that devices perform their critical functions. Our attention to detail helps customers meet their 510(k) submission standards, saving time and costly production fumbles.

Our cost-effective approach as a full-service medical device manufacturing company covers your medical device from concept to market. You must have confidence in our ability to develop, manufacture, and certify your product. As an ISO13485-compliant company, HDA values and prioritizes the quality and safety of its products. That’s why our personnel, standard, and experience reflect the values of an industry-leading medical device manufacturer. Additionally, HDA’s FDA and FDB certifications highlight our commitment to regulatory responsibility and quality assurance.

HDA Handles Post-Market Surveillance (PMS)

HDA’s goal is to continuously develop safe, effective products that benefit users and patients. We’re committed to ensuring that our devices remain safe and effective once they’re in their real-world environments. HDA manages PMS on each unique device.

We mitigate risk with stringent testing procedures and protocols throughout the development process. Additionally, HDA emphasizes its commitment to safe and functional products by maintaining a PMS system and reporting events to the relevant regulatory bodies. We track and report on all medical devices regardless of how it’s classified.

HDA utilizes a PMS system to address manufactured products in the real world:

• Detected and reported unintended outcomes involving our products
• Testing device functionality against real-world use
• Maintain device compliance with shifting regulatory requirements
• Ensure the safety and effectiveness of medical device products

As part of HDA’s after-sale support, we utilize reporting data to address and correct any unintended outcomes of our medical devices. We believe this proactive process is essential to delivering reliable, effective medical device products and ensuring the safety of consumers and patients that rely upon them.

Contact Us Today

Bring your new, innovative medical solution to one of Southern California’s long-time leading product development companies. HDA has experience working with companies of a wide variety of sizes, and our solutions scale to meet projects of any size.

Let’s get started! Reach out today for a consultation on your product development and manufacturing needs.

SERVICES

HDA provides contract manufacturing, prototype production, and compliant pilot production to the medical device and IVD industries. Our customers include medical startups, mid-size companies, and multinational corporations. We have developed refined development and manufacturing processes that can take your product through its complete lifecycle — from concept to delivery. HDA’s reputation for quality and reliability makes it one of the leading contract manufacturing companies in Southern California.

By combining the technical expertise of our full-service development team, we consistently deliver high-quality results to our valued customers. We have industry-best engineers, regulatory specialists, and development professionals ready to make your medical device a success. Our robust quality management system and decades of manufacturing experience guarantee reliable, functioning products. HDA approaches each project with a craftsman’s eye and dedication to providing excellence. 

There aren’t many manufacturers like HDA. Our blend of size, experience, and resources, allow us to scale quickly and responsibly to fit your company’s unique needs. You can be confident that every unit of your product will be well-built, reliable, and to your exact specifications. Production volume ranges from 5-50 compliant pilot units for clinical testing to hundreds or thousands of units per month for commercial production. We build durable medical equipment and disposables in our FDA-registered facility in Orange County, California.

Medical Device Contract Manufacturing Services

HDA is capable of handling your product’s manufacturing process from start to finish. From sourcing your entire Bill of Materials (BOM), developing the necessary manufacturing processes, and implementing required test systems, HDA Technology will deliver cost-effective and reliable results. Our lean manufacturing practices allow us to handle any order volume — ranging from low-volume to high-volume — to meet your production demands. 

We can quickly and efficiently optimize our large production facility to match your product’s production requirements. Our manufacturing facility is easily reconfigurable, allowing us to minimize lead time when starting production on your product. We prioritize lean manufacturing processes to our customers with reliable, cost-effective production services.

HDA’s lean manufacturing process offers many benefits to you:

• Cost-Effective Production. By sourcing only the necessary amount of raw materials, optimizing the manufacturing process, and reducing wasted efforts during production, HDA ensures you don’t get stuck with bloated manufacturing costs.
• Consistent Quality. Our full-service production team has the experience and expertise to make sure that your order is done right the first time. We have tried-and-true quality assurance and production procedures in place to guarantee high-quality products every time.
• Streamlined Manufacturing. We reduce lead times by eliminating unnecessary processes and slowdowns in production. Our efficient manufacturing methods eliminate wasteful and unnecessary processes during development. Our priority is to produce safe, functional products as quickly as possible.
• Large Scalability. HDA has the capacity to match your order size no matter the size. We provide fast turnaround on high-volume orders because of our efficient production practices. We’re able to comfortably scale to meet mass volume production goals while still accounting for quality and reliability.

Our full-service production process optimizes the manufacturing process to provide you with an easy, trouble-free experience. Are you looking for a medical device contract manufacturing company that provides specialized services? We specialize in a number of manufacturing and support services to meet any challenges your company may encounter.

Compliant Pilot Production

Are you in need of a cost-effective contract manufacturing solution to support your 510(k) filing or clinical testing? HDA specializes in Compliant Pilot Production to help your company get its product closer to the market. Our FDA-certified production facility produces fully compliant orders that will help you mitigate compliance delays and failures. 

Prototype Production

Prove your medical device’s critical function and design with a high-quality prototype. This essential stage in the development process evaluates the efficacy of your product before it goes to the mass manufacturing stage. HDA’s prototype production process saves time and money by testing your product before design mistakes complicate manufacturing. Our production facility is staffed by experienced engineers and technicians that can make your concept a reality.

No matter your needs, HDA can help your company achieve its goals. Our manufacturing and support services include:

• Purchasing and BOM Management
• Compliant Clinical Unit Production
• Prototype Production
• Volume Production
• Box Build
• System Build
• Disposables
• Optical
• Radio Frequency
• Calibration
• Test
• After-sale Support and Service

RESOURCES

As a full-service medical product development and manufacturing company with decades in operation, HDA has developed an extensive amount of resources to aid the development of your unique product. Leverage our resources and knowledge to properly and efficiently manufacture your innovative medical device concept.

HDA has the resources and certifications to help you:

• Large, open manufacturing floor
• Lean Manufacturing Process
• ISO 8 Cleanroom
• Thermal Test Chamber
• Easily Reconfigurable Facility
• Climate Controlled, ESD-Safe
• FDA- and FDB-registered
• ISO-13485 Certified
• Decades of experience

FDA AND FDB REGISTERED

ISO CERTIFIED QUALITY MANAGEMENT SYSTEM

Our robust quality system allows us to provide you with world-class products throughout their life cycle. This means better designs, complete documentation and safe, effective and reliable products in the field.

We believe that our commitment to quality is crucial to your success, and continue to invest in our people and quality management system (QMS) to ensure that we deliver the best value to our clients by using well-established development, production and documentation methods.

HDA is certified to ISO 13485 for the design and manufacture of medical devices, and registered with the FDA and California FDB to manufacture medical devices.