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.
Technical Director
John represents regulatory affairs on the board. He manages our quality management system, as well as ensuring tools and systems are in place for the teams to effectively perform.
John holds a Bachelor’s Degree in Industrial and Product Design along with over 15 years’ experience in medical device development. John has particular expertise in the design, development and industrialisation of medical electrical equipment.
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