Learn About Medical Device Compliance

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How should changes to a QMS unrelated to the product be tracked under MDR?

Anonymous • 1 comment

13 days ago

During a recent MDR audit, a minor non-conformity was issued because changes to our quality management system (QMS) that are not related to the product (such as changes in company leadership or new lo

Accepted answer

In my case, I don't have a separate SOP for this type of change, but I mention it in the management SOP and keep a record for tracking process changes

How is medical device regulation developed and how can its usability be improved for start-ups?

Anonymous • 1 comment

14 days ago

I am interested in understanding how medical device regulation, specifically the MDR, is developed and what could be done to improve its usability, especially for small start-ups. From my experience a

Accepted answer

Regulation like the MDR is developed at the EU level as part of the "new legislative framework" for product safety. The process involves EU institutio

How should IVDR Annex I, Article 9.1(a) requirements be addressed for SaMD-IVDs in the GSPR?

Anonymous • 1 comment

16 days ago

I am preparing the General Safety and Performance Requirements (GSPR) for a software as a medical device (SaMD) intended for in vitro diagnostic (IVD) use and have a question regarding IVDR Annex I, A

Accepted answer

You're right that not all aspects of Article 9.1(a) make sense for SaMD-IVDs, but it's generally not correct to mark the entire requirement as 'not ap

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

Anonymous • 1 comment

18 days 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 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