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ISO 13485 COMPLIANT MEDICAL PRODUCT DESIGN

MEDICAL DEVICE DEVELOPMENT SERVICES

We are passionate about creating important new products that improve people’s lives.

FROM MEDICAL DEVICE CONCEPT DEVELOPMENT THROUGH PRODUCTION

Medical Device Development Services and Resources

The team of medical development professionals at HDA brings decades of experience to providing innovative medical device development services. HDA has a proven track record in medical device development, and our team will work with you every step of the way to ensure your product meets both regulatory requirements and market needs.

We produce proof of concept prototypes and first articles quickly and efficiently, saving you time and money. Our medical device projects have ranged from developing a testing system for medical ultrasonic transducers to creating intelligent surgical bone drill systems. Whatever your project entails, HDA will provide the necessary medical device development services to get you to market quickly and efficiently.

The first step in any medical device development project is concept development. This is where we work with you to generate ideas, flesh out concepts, and develop prototypes. Our team has a wealth of experience in medical device development, and we can help you take your idea from concept to reality.

Pre-compliance testing in-house is also part of our development process, ensuring that your product will pass certification testing as quickly as possible. HDA designs compliance into each project; passing on the first try is normal for us.

Our engineering and development services are ISO13485-compliant, so you can be confident that your product will meet the highest quality standards. We are ISO13485 certified and are registered with the FDA and FDB. Orange County, California has been our home for over 35 years.

We offer a number of services to help with medical device concept development. Read more about them below.

If you’re looking for a partner to help you develop a new medical device, look no further than HDA. We offer a complete range of medical device development services to help bring your product to market quickly and efficiently. Contact us today to get started.

Services

  • Electronic Design
  • Software Development
  • Mechanical Engineering
  • Industrial Engineering
  • Systems Engineering
  • Concept Development and Refinement
  • Process Development
  • Feasibility Evaluation
  • Human Factors (Usability) Engineering
  • Pre-compliance Evaluation and Testing
  • Compliance Mitigation Consulting
  • FDA ready design and documentation package
  • Prototype and Clinical Device Assembly and test
  • Transfer to Manufacturing
  • Manufacturer Evaluation and Recommendation
  • Contract Manufacturing

Capabilities

  • ISO 8 Cleanroom
  • LN2 Temperature Chamber
  • Screen Room
  • RF and EMC Analysis
  • EMC Test
  • ESD Test
  • Power quality and analysis
  • Magnetic RF field tissue phantom testing
  • IEC60601 compliance verification and mitigation
  • FDA 510(k) Support
  • Root Cause Failure Analysis
  • Lost Design Recovery
  • Reverse Engineering
  • Reliability Enhancement
  • Documentation and Design Remediation
  • Design for Manufacture Evaluation

Platforms and Tools

  • Altium Designer
  • Cadence Allegro/OrCad
  • Solidworks
  • Spice
  • Sonnet
  • Altera Quartus II
  • Xilinx ISE
  • Android, Linux, Windows, RTOS
  • ARM
  • C/C++, Java, Scripting Languages
  • QT
  • Antenna Design
  • Bluetooth
  • Cellular
  • Discrete RF Design
  • GPS
  • WiFi

Quality Medical Device Development Services

As an ISO13485-certified facility, HDA is committed to providing the highest quality medical device development services. Our team is ready to take on your project, no matter how complex it may be.

ISO13485 certification means that our quality management system has been audited and found to be in compliance with the international standard for medical devices. This certification is required for companies that design, develop, manufacture, or distribute medical devices.

The FDA regulates all medical devices sold in the United States. In order to sell a medical device in the US, it must be registered with the FDA and comply with their regulations. The FDA requires medical device companies to submit a premarket notification, or 510(k), for most Class II and III medical devices.

The FDB (Food and Drug Branch) is part of the California Department of Public Health. They regulate food, drugs, cosmetics, and medicinal devices that are sold within the state of California. Companies that make or sell medical devices in California must register with the FDB.

HDA is committed to helping our clients bring their products to market quickly and efficiently. We offer a full range of medical device development services, from concept development through to production. Explore our medical device contract manufacturing services as well. We also offer compliance consulting to help you navigate the regulatory landscape. Contact us today to learn more about how we can help you with your next project.

It’s time to get started, and HDA is here to help. Work with our experts to design your next medical device prototype in an efficient, timely, and affordable manner.

LET’S GET STARTED

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