Among medical device contract developers and manufacturers, no two companies are alike. One key differentiator is their level of adherence to standards and certification. Understanding why a contract manufacturer has established certain management procedures and how they are enforced will help you decide whether they are the right fit for your purposes. ISO 13485 is a critical certification, so we’re starting there and discussing its key role in medical device development.
We’ve also built this article as an overall primer to introduce you to HDA Technology, our certified quality system, and its many benefits and attributes.
Why Do Standards and Certifications Matter?
Precision, risk management, and reliability are paramount in medical device manufacturing. We have decades of experience to prove it.
A company’s quality system defines the effectiveness and consistency of its internal processes. A good quality system can define a company’s development, manufacturing, and product lifecycle management procedures. In the medical world, where manufactured products are used to diagnose, treat, and improve quality of life, this definition becomes critical for ensuring the highest level of safety possible.
As a medical device contract manufacturer operating in low and mid-volume spaces, we understand the critical role that standards and certifications play in every sphere of the industry. At HDA, our willingness to take on smaller clients also comes along with a customer and product focus that is quality-driven rather than cost or throughput-driven.
Patient Safety is Non-Negotiable
The stakes are always high for medical device development, regulatory work, and manufacturing. There’s a direct line between the quality of devices, the success of procedures, and the health and well-being of patients. We know our clients want to prioritize positive patient outcomes.
Adherence to standards and the certification process serves to safeguard against potential hazards. Standards establish clear guidelines for product design, manufacturing processes, and quality control, ensuring that every medical device meets predefined safety standards. Compliance with these standards is not optional; it’s a moral, ethical, and legal obligation.
Consistency and Reliability
The medical industry relies on consistency and reliability. Patients, physicians, and healthcare institutions need to trust that a device will perform as expected every time it’s used. Standards and certifications create a framework for consistency with these electronic devices by defining specific requirements for materials, manufacturing processes, and quality control. This consistency manages risk, builds trust among stakeholders, and ensures that medical devices maintain their effectiveness throughout their lifecycle.
HDA Technology specializes in electronic equipment, both durable and capital; our adherence to standards ensures a consistently high level of quality in every device we work on. With us, you know exactly what to expect, and you know it’s good.
Regulatory Compliance
Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have stringent requirements for medical devices. Manufacturers must navigate complex regulatory pathways in this country — as in all others — to bring their products to market.
Standards and certifications align with these regulatory requirements, making the approval process smoother and faster. They act as a roadmap, guiding manufacturers through the necessary steps to meet compliance, and reducing the risk of costly delays or product recalls.
Our company works with both U.S.-based businesses and startups as well as internationally-oriented clients, and we are committed to following this roadmap.
What Is ISO 13485?
ISO 13485 is an internationally recognized quality management system standard designed specifically for medical device manufacturers. It is derived from ISO 9001, which is used in many industries as a gold standard. You may encounter development and manufacturing companies that proudly claim ISO 9001 certification, but are without ISO 13485. The latter standard specifically outlines the requirements for a comprehensive quality management system tailored to the unique needs of the medical device industry. As a result, while being ISO 13485 certified guarantees ISO 9001 certification too, the inverse is simply not the case.
ISO 13485 is, at its core, a quality improvement methodology: it forces developers and manufacturers to do high-quality work from the get-go and to improve systematically from there. Compliance with ISO 13485 signifies a commitment to ensuring the safety and effectiveness of medical devices, which is of paramount importance in healthcare.
ISO 13485 for Low-Volume Electronic Medical Device Manufacturers
At HDA Technology, we pride ourselves on working not only in high-volume production but also with startup and early-stage companies in the low-volume sphere. While ISO 13485 applies to all medical device manufacturers, it holds particular relevance for companies specializing in low-volume electronic medical equipment like HDA. Here’s why:
Regulatory Alignment
Simplified Regulatory Compliance: ISO 13485 harmonizes with various international regulatory frameworks, including the U.S. Food and Drug Administration (FDA). Development and manufacturing companies like HDA Technology work regularly in the international market.
This harmony simplifies the regulatory compliance process – first, for low-volume clients interested in an international market, and second, for low-volume clients who are undecided when they begin their work, but may later want to expand.
Quality-Focused Culture
Commitment to Excellence: ISO 13485 integrates a culture of continuous improvement into your company’s work. In low-volume manufacturing, every device counts, and quality is non-negotiable. Adhering to ISO 13485 builds an environment where every aspect of the development and manufacturing process is methodically scrutinized and optimized for quality, even for low-volume production runs.
Risk Reduction
Proactive Risk Management: In low-volume electronic medical equipment manufacturing, errors can be costly for your finances and reputation. ISO 13485’s emphasis on risk reduction and management helps manufacturers identify potential issues early in the development process, reducing the likelihood of unnoticed defects and costly recalls.
Documentation and Traceability
A Keen Eye for Details: ISO 13485 mandates comprehensive documentation of all processes, from design to production. In low-volume manufacturing, where product knowledge may be concentrated in a few experts, this documentation ensures that vital information is retained and can be transferred seamlessly from one phase of production to the next.
Supply Chain Control
Ensuring Supplier Reliability: For low-volume manufacturers, maintaining control over suppliers and ensuring their compliance with quality requirements is crucial to maintaining consistent product quality. ISO 13485 emphasizes the importance of using qualified suppliers and monitoring their continued performance, which reduces the risk of supply chain-related roadblocks.
Enhanced Customer Trust
Confidence in Product Quality: Healthcare professionals and institutions rely on medical devices for patient care. ISO 13485 certification provides assurance that the devices are produced in a controlled and quality-focused environment, enhancing customer trust and confidence in your products.
Scalability
Preparedness for Growth: Low-volume manufacturers often aspire to scale up as product demand increases. ISO 13485 provides a solid foundation for growth by maintaining unshakeable quality standards which help companies transition smoothly from design into production.
Global Market Access
International Acceptance and Opportunity: The medical device industry is global, and manufacturers often aim to reach international markets. Devices that meet internationally recognized standards can be more likely to gain acceptance in various markets, making it easier for manufacturers to expand their reach and serve a broader customer base.
Because we work with both U.S.-based businesses as well as internationally-oriented clients, we know that standards and certifications help to bridge the gap between different countries’ regulatory requirements. We want our clients to have every opportunity to widen their reach, and our adherence to these standards makes it all that much easier.
Competitive Advantage
Stand-Out Quality and Reliability: In a crowded marketplace, standing out is essential. Achieving and maintaining standards and certifications can give a manufacturer a significant competitive advantage. It demonstrates a commitment to quality, safety, and continuous improvement, which can resonate with customers and partners.
By being certified, HDA Technology shows your customers the quality and reliability of your products – giving your product a competitive edge, and you the ability to stand out in both local and international markets.
Risk Management and Reduction
No More Costly Recalls: Errors, defects, and recalls can be costly – both financially and reputationally. Standards and certifications serve as proactive risk reduction tools. By following established guidelines and best practices, we manufacturers reduce the likelihood of production errors and defects. Moreover, adhering to these standards can help identify and address potential issues during the design and development phases, preventing costly recalls and protecting the brand’s reputation.
The combination of our certification and our breadth of experience smooths out your path to market significantly.
Innovation and Advancement
Open the Door to the Future: Standards and certifications are not static; they evolve in response to advancements in technology, changes in regulations, and emerging safety concerns.
By complying with these standards, HDA both contributes to and participates in the industry’s ongoing innovation and advancement. We play a small part in helping to shape the future of medical device technology while ensuring that it remains safe and effective.
Confidence for Healthcare Providers
Ensuring Provider Safety: Healthcare providers are on the front lines of patient care and safety. They rely on medical devices to make critical decisions and provide the best possible treatment. When healthcare providers know that a medical device is certified and meets established standards, they can have confidence in its performance. This confidence is not only essential for delivering high-quality healthcare and ensuring positive patient outcomes – it also keeps providers safe from the physical, emotional, and legal risks of unreliable devices.
We know that the relationship between providers’ confidence and security and patients’ outcomes and safety is iterative. Our goal is to ensure both, as consistently as possible.
Long-Term Cost Savings
Strategically Avoid Unexpected Costs: Investing in standards and certifications may require up-front time and resources, but it pays off in the long run. By adhering to these standards, manufacturers reduce the likelihood of costly product recalls, legal liabilities, and reputational damage. Additionally, a commitment to quality can lead to improved operational efficiency and reduced waste, resulting in cost savings over time.
While the opposite may at first appear to be true, we have the experience to back us up. We often meet clients who have found out the hard way that adherence to standards and certifications is a major cost-saver.
Ethical Responsibility
Prioritize Harm Reduction: Manufacturers have an ethical responsibility to prioritize patient safety and well-being. Standards and certifications provide a clear path for fulfilling this responsibility. By adhering to these standards, manufacturers can demonstrate their dedication to producing devices that not only meet regulatory requirements but also contribute to improving healthcare outcomes for patients worldwide.
At HDA Technology, we demonstrate this dedication in every single step of our process.
To summarize, standards and certifications are a key backbone of the medical device manufacturing industry. They ensure patient safety, drive consistency and reliability, facilitate regulatory compliance, and offer numerous benefits to manufacturers and users alike. At HDA Technology, we are committed to adhering to the highest industry standards and certifications to produce safe and reliable medical devices that contribute to a healthier world.
The ISO 13485 Medical Devices Quality Management System
We’ve discussed standards and certifications from a general perspective and jumped into context on 1SO 13485. Let’s touch base again on the key ways in which HDA’s adherence to ISO 13485 differentiates us from competitors and benefits our clients. As a reminder, ISO 13485 is the primary controlling quality standard used in the medical industry, while AS9100 is the top-level standard used in aerospace. ISO 9001 is used in many industries and is the quality system from which both ISO 13485 and AS9100 are derived.
ISO 13485 Saves You Money
Working with a development firm with a certified quality system saves time and reduces costs.
No matter how good a job you think you are doing, there will almost always be something that doesn’t quite meet the exacting quality of regulatory standards. The only way to know for sure whether your work meets the standard is to conduct regular audits throughout the development and manufacturing process. A certified company like HDA Technology has these regular check-ins embedded into every step of our process. With us, you will never have to worry that your final product won’t be up to snuff.
Many design firms claim that by not becoming ISO certified they will save you money. Their usual rationale is that they are compliant on their own so you will get the benefits without the cost.
In reality, the cost of certification is a very small part of a typical firm’s overhead, and the resulting improvements to the development process serve to reduce development costs and reduce program risk. The only way for a quality system to be compliant is through verification with regular audits – audits that ISO 13485 certification builds seamlessly into your system.
The Quality Assurance System You Need
In an ISO 13485 environment, like the one we have at HDA Technology, the goal of the system is to achieve continual improvement in effectiveness, quality, reliability, and yield. At HDA, certification is just as important for shaping design activities as it is for guiding manufacturing processes. The purpose of a quality system during product development is to ensure that products are designed using procedures and processes that enforce thorough and effective planning and risk mitigation methodologies.
This serves two important purposes: it ensures that all necessary features are designed into the product from the beginning, and it prevents the unnoticed inclusion of deficiencies.
Consider a situation in which a deficiency is discovered during a later testing phase, or worse yet, when volume production has been released into the field. These problems, when found late in the process, can be costly to correct. Likewise, an important product feature or requirement that is omitted from a design during development is much more costly, if not impossible, to implement later in the program.
During manufacturing and throughout the product lifecycle, a properly executed quality system ensures that every product built will meet customer and regulatory requirements. When problems are discovered in a finished product, the quality system provides a process for identifying the defect, determining its root cause, and implementing the corrective action to be taken so that the problem does not recur.
External Checks and Balances
Because our company is ISO 13485 certified, we are audited regularly by internal auditors and by external registrar auditors. This ensures that 1) we, alongside all other certified companies, are following our quality system faithfully, 2) our quality system conforms to the current standard, and 3) we are always improving our systems.
Our registrar, NAB, schedules audits on a one- or two-year cycle, depending on the length of time a company has been registered. Our practice is to hire an independent auditor to verify our compliance at about the midpoint between our registrar’s surveillance or recertification audits, ensuring that we remain compliant and up to date. A company that claims to be compliant without submitting to the certification process and regular audits is, by definition, non-compliant.
Maintaining our quality systems in full compliance is a cornerstone of ensuring that we develop safe and efficacious products for our clients and that the products we manufacture are reliable and meet customer and regulatory requirements, whether for medical, aerospace, or other markets.
HDA is registered to ISO 13485 for the design and manufacture of medical devices. We are also registered with the FDA and California FDB to manufacture medical devices.
If you have additional questions about our certifications and standards or would like to request a consultation, you are invited to get in touch.
