SMEDTEC

EU MDR IVDR FDA

SMEDTEC is a United Kingdom regulatory consultancy for medical devices, IVDs and other health technologies. Its consulting work includes regulatory strategy, fractional regulatory and quality leadership, submissions, post-market surveillance and embedded RA/QA roles. The firm states experience with EU MDR, IVDR, FDA and MHRA requirements and also offers UK Responsible Person and EU Authorised Representative services alongside regulatory operations software.

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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

Uncategorized

Authorised Representative For Non-EU Manufacturers

Updated about 1 year ago

Sebastian Skorka

14:05

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

Dr. Oliver Eidel

19 views · 9 months ago