QualiFest

EU MDR FDA

QualiFest is the independent Belgian medical device quality and regulatory practice of Niels Festjens. He supports manufacturers and suppliers with EU MDR and FDA requirements, including ISO 13485 and 21 CFR 820 quality systems, CE technical files, 510(k) submissions, gap analyses and interim quality management. The practice is based in Sint-Katelijne-Waver and works with companies needing hands-on QA and RA support.

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FDA Compliance

The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR

Updated about 1 year ago

Sebastian Skorka

Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software

How to generate EUDAMED ID DI for MDD devices and what manufacturer device code is needed?

Anonymous · 1 comment

6 months ago

When registering MDD devices in EUDAMED using the EUDAMED ID DI, is a manufacturer device code required, and where can it be obtained? Does EUDAMED generate the EUDAMED ID and DI automatically, or doe

Accepted 7 answers

After ISO 13485 certification, you should close out any audit findings and address them in your Corrective and Preventive Actions (CAPA) process. Expe