When is a QMS required for medical device development?

Question

At our company, we are preparing to implement a Quality Management System (QMS) and are unsure about the timing. Is a QMS required during the development phase, or only when preparing to put a medical device on the market?

Dr. Oliver Eidel · Accepted Answer

Ideally, you would have your QMS in place before the development phase starts. In reality, most companies implement it during the development phase, since the QMS includes your processes for design and development. You don't have to wait until your device is on the market to implement the QMS.
For certification, it's a bit different. You can (and should) have a working QMS before or during development, but certification (like ISO 13485) is typically required before you go to market. In the EU, if your product is class IIa or higher, you'll need a notified body to audit your QMS as part of the conformity assessment, usually before they review your technical documentation.

Answer

There is a helpful article on this topic: https://openregulatory.com/develop-software-or-set-up-qms-first/

When is a QMS required for medical device development?

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