Correct planning should be carried out to control the design & development of your medical device. However, many companies fall short when it comes to their documentation and overall approach to planning. But, is a design & development plan a regulatory requirement?

To market and sell your medical device in Europe, you will need to comply with the Medical Device Regulation [MDR], and in the United States, with title 21 Part 820 of the Code of Federal Regulations [CFR]. HD’s process and systems follow the international ISO 13485 standard & the Code of Federal Regulations in the United States. According to 7.3.2 of ISO 13485, the international quality management system standard for medical devices, and FDA 21 CFR Part 820.30 (b), the quality system regulation for medical devices in the United States, plans for the design and development of a medical device shall be documented in a Design and Development Plan. The Design & Development Plan is a living document and shall be reviewed, updated, and approved as the project progresses.

ISO 13485 and the FDA’s CFR outline some loose guidelines for the development plan. The standard dictates that you need procedures in place and, to an extent, the requirements of those procedures. However, they don’t necessarily tell you what the procedure needs to be. Therefore, you’re required to write your own procedure. This is one of the reasons that there is often a lot of confusion surrounding the topic.

At HD, we have our own design & development procedure for medical device projects. We created this process internally utilising the experience of our team paired with our network of industry experts. Additionally, we have procedures in place to cover the requirements of ISO 14971, Risk Management for medical devices – another important factor to consider when planning the development of a medical device. We have also previously assisted pharmaceutical and healthcare clients with the development of their own set of audited systems and procedures as an essential part of developing and launching a medical device.

It’s important to note that a design development plan isn’t a ‘one size fits all’ activity neither for specific projects or companies.

Please visit our resources page to learn more and download a copy of our free guide on How to Plan the Design & Development of a Medical Device.

John Harverson - Senior Medical Device Design Development Engineer & Quality Manager at Haughton Design John Harverson 1 March 2023

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Get in Touch with John Harverson

Technical Director

Holding a Bachelor’s degree in Industrial and Product Design as well as certificates in Project Management and UX Design, John is an advocate of user-centred design and finding innovative solutions within regulated fields. With over a decade’s experience in the medical device industry from working as a Consultant helping companies develop innovative medical devices, to head of an Industrial Design company developing imaging equipment for early detection of breast cancer, John also manages our ISO 13485 & ISO 9001 QMS.

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