ISO 13485 Certified For Complete Medical Device Development

April 2, 2018 akozlowski

ISO 13485 Certified For Complete Medical Device Development

Enhancing our services for medical device clients, Priority Designs is pleased to have received ISO 13485:2016 certification from the British Standards Institution (BSI). This standard represents the requirements for a comprehensive management system for contract design and development of medical devices, and we look forward to further expanding our offering in device design and development, design control and risk management, and ultimately transfer to manufacturing.

The ISO 13485 standard provides a framework for the Quality Management System we have in place. It ensures our processes, systems, documentation, and records meet regulatory scrutiny and regulatory compliance to design and develop a medical device. We use a validated electronic Quality Management System (Greenlight Guru) that is compliant with 13485, along with the ISO 14972 and Title 21 CFR Part 11.

Our medical device design and development capabilities include user research, design, engineering, prototyping and soft goods development. Customers include Abbott Medical, Johnson and Johnson, Cardinal Health, Midmark, MarCor, and many others.

"We live at the intersection of form and function, are passionate about solving problems creatively, and thrive in the ever-changing world of healthcare."

Medical User Research

We view research as the foundation of any successful development activity and consider it critical in medical device development. Early contextual research creates a direct, traceable link between user needs and product requirements; in addition to allowing the team to focus on developing a safe and effective device from the inception of the project.

Our fully credentialed research team has conducted thousands of hours of usability research in clinical settings across the globe. These same researchers continue to be champions for the users across the entire development activity, often lending their key insights into the risk assessment activities. All this culminates into a streamlined development activity, as the Priority Designs research team understands the downstream impacts of the upfront research.

Design and Engineering

Design has been at the core of Priority’s capabilities for 25+ years. Our industrial designers and soft goods experts work seamlessly with the research, engineering, and human factors teams to create relevant solutions for our healthcare clients. We live at the intersection of form and function, are passionate about solving problems creatively, and thrive in the ever-changing world of healthcare. A great design is only as good as the execution, and our team of engineers ensure products are engineered for the real world. Our engineering team includes Mechanical, Electrical, Software and Biomedical Engineers who understand the technical risks and strive to move your device from concept to production as efficiently as possible.

Prototyping Medical Devices

Our 20,000 square foot prototyping facility is a testament to our belief in the value of prototyping. Machining, 3D printing, casting, welding, laser cutting and more are all available just across the studio from our researchers, designers and engineers. Our dedicated team of prototype specialists have the ability to fabricate products from proof-of-concept for early testing, all the way through fully functional working models.

Soft Goods Development

While others have closed their internal labs in favor of outsourcing, we continue to expand our capability and invest in new equipment. A clear example of this is our STOLL 7.2 Multi-gauge CMS ADF-32W digital knitting machine. With this machine, we use digital pattern programming to create seamless and knit to shape products. Multiple materials can be integrated into a single production-level prototype. These machines can incorporate over thirty different yarn types, including carbon fiber and conductive materials, inlayed with the fabric. With its highly controlled and precise design capabilities, digital knitting transforms the material into an engineered textile with specific functional purposes. This system has proven invaluable in our medical wearable category, enabling us to push the envelope in wearable technology. To learn more about our full prototyping capability, visit our prototyping page here:

Human Factors Testing

Human Factors means more than “easy to use”. The FDA encourages human factors activities as a risk management activity during all stages of device development and continues to increase the scrutiny of Human Factors activities during the submission process. Priority Designs’ Human Factors team has deep experience in the design and execution of formative and summative human factors studies ranging from simple Instructions for use testing, full scale hardware and software system evaluations, to actual use studies as part of clinical evaluations. We have conducted these studies in our onsite usability lab and in partner facilities across the globe.

Customized Consulting For Every Project

Achieving ISO certification demonstrates Priority Designs has successfully implemented a Quality Management System (QMS), committing to the continual improvement of the quality of services provided to our customers, as well as the ability to understand the ever-changing regulatory constraints of the medical device design and development lifecycle. Priority Designs is a contract design firm, therefore, each project is different. Some projects are in the early stages of research and development and do not require the QMS however, some projects require full-blown design controls and risk management services. Either way, Priority Designs is committed to excellence and providing our customers with service that is above and beyond expectations.

Want to receive new articles and updates? Join our email list.

About The Author

Reade Harpham, Sr. Medical Device Specialist

Although he’d rather be kayaking, Reade is passionate about design and integrating end user insights into the product development process. For the past 15 years, Reade has brought a pragmatic, user centric view to clientele in the highly regulated medical device industry. An invited author and speaker on the international stage, Reade has extensive experience in research, design and human factors, and has been named on numerous design and utility patents. His bold socks may not always match his outfits, but Reade is certainly a great match to the world class development team at Priority Designs.

  • SHARE: