How to prepare for MDR QMS audits by Notified Bodies?

Anonymous · Published February 28, 2026 · 1 comment

What are some effective strategies to prepare for MDR (Medical Device Regulation) QMS (Quality Management System) audits conducted by Notified Bodies? Are there specific internal audit practices or auditor qualifications that can help avoid major non-conformities?

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

Anonymous 3 months ago

Great practical tip! Did you have to provide evidence of auditor qualifications to the NB?

Reply to this comment

Discussion

3 Answers

Accepted answer available

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory · 4 months ago

It's really important that your internal auditors are qualified for the subjects they're reviewing, including MDR. Notified Bodies will check this. Also, if you can, have your internal audit results discussed in a management meeting before the NB audit. This can help update resource plans and address any issues proactively.

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

No comments yet. Be the first to share your thoughts.

Anonymous · 4 months ago

Make sure your internal audit covers the MDR requirements in scope before your Notified Body audit. Having a qualified internal auditor who understands MDR is critical. We almost had a major non-conformity because the internal audit didn't fully address MDR requirements.

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

No comments yet. Be the first to share your thoughts.

Anonymous · 3 months ago

Both points above are true. You'll definitely get a major NC if you haven't done an internal audit with auditors who are familiar with MDR. And discussing the audit in a management meeting helps, since it gets resources allocated to fix any gaps before the NB audit.

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

No comments yet. Be the first to share your thoughts.

Want to add your answer to this question?
Write an answer under your name by logging in or signing up, or post anonymously.

Keep reading

All questions

Is a new QMS audit required for MDR certification if we already have MDD and ISO 13485 certification?

Anonymous · 1 comment

4 months ago

Our company has a device certified under the MDD with a certified QMS (quality management system). We are planning to transition to MDR certification. Do we need to undergo a new QMS audit according t

Accepted 6 answers

For our company, the stage I audit was a verification of our QMS specifically against MDR requirements, and then we sent in our technical documentatio

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

SOP Internal Audit

Sven Piechottka

updated about 2 years ago

Still have a question? Ask a question here publicly — for free.

Or talk to one of our consultants — first calls are free. Check out our services and prices.

Looking to automate your regulatory work? Check out our eQMS, Formwork. Built for lean, founder-led companies. There’s a free version too.