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Quality Management 2 answers

When is a QMS required for medical device development?

Anonymous · Published June 18, 2025 · 1 comment
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?

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Emily Carter 12 months ago
Is this the same for class I devices in the US/FDA context?
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2 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
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.

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All questions
A

Is it necessary to have technical documentation ready before certifying a QMS under MDR for a class IIa medical device?

Anonymous · 1 comment
12 months ago
Our company wants to certify its Quality Management System (QMS) as soon as all documentation is ready, but we do not yet have all the technical documentation for our medical device completed. Based o
Accepted 1 answer

It's generally fine to proceed with certifying your QMS before the technical documentation for your device is complete, especially if you are aiming f

A

Is it necessary to have technical documentation ready before certifying the QMS under MDR for a class IIa device?

Anonymous · 2 comments
12 months ago
We are preparing to certify our Quality Management System (QMS) but do not yet have all of the technical documentation for our medical device completed. According to MDR 2017/745 (Annex IX, Chapter 1,
Accepted 4 answers

Certification to ISO 13485 is independent from being a manufacturer under MDR Annex IX. Many certification bodies are not Notified Bodies for MDR, so

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Is ISO 13485 certification required before CE marking for medical device software in the EU and Switzerland?

Anonymous · 1 comment
about 1 year ago
Our company is planning to certify our software as a medical device in the EU and Switzerland. We have two questions: • Is it necessary to obtain ISO 13485 certification before pursuing CE marking? Wh
Accepted 1 answer

One of the requirements for CE marking, depending on the classification of your device, is that you have a certified QMS in place. The MDR requires ma

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