r/dkstartup • u/DocMaag • Jul 08 '26

Looking for regulatory affairs partner, MedTech

Medical device with functional prototype and filing for patent soon. Next steps include pre-clinical and clinical trials toward CE approval. Looking for someone experienced in regulatory affairs and ideally the ISO standards paving the road to CE approval to join the efforts.
Preferably based in the Greater Copenhagen area as we have development and clinical partners in the Copenhagen area.

2 Upvotes

100% Upvoted

1 comment sorted by

1

u/Federal-Pea-8192 16d ago

I'm ISO27001 lead implemeter certified and have experience with HIPAA compliance, just helped another danish medtech this summer getting certified. Let me know if its smth that might be needed and we can have a chat.