SereniHealth

EU MDR IVDR

SereniHealth is an independent UK quality and regulatory consultancy for medical device and IVD manufacturers, operating from Manchester and registered in Belfast. Its services include EU MDR and IVDR readiness, regulatory strategy, technical-documentation structures and notified-body audit preparation. The team also supports ISO 13485 quality systems, PRRC responsibilities, post-market surveillance, CAPA processes and electronic quality-system improvement for manufacturers working across European and other markets.

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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

14:05

EU MDR Post-Market Surveillance, Part 2 (+ ISO 13485)

Dr. Oliver Eidel

19 views · 9 months ago

SaMD : Is the frontend part of the medicla device under EU MDR ?

Anonymous

8 months ago

In a CE-marked SaMD under EU MDR, only the backend of our software performs the medical function (clinical data processing, rule evaluation, alert generation). The frontend performs no medical logic a

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