To be prepared for the challenge of the MDR we strengthen our team with two proven QM/RA-Experts.
We are pleased to welcome Daniel Fehr on board, a solution-oriented project manager and experienced expert for biocompatibility, MDSAP audits and product approvals. His ability to combine dynamics with pragmatism makes him a perfect match for our inmedis crew.
And even more power at inmedis! With his many years of professional experience in the medical device industry Willy Amstutz is a perfect complement to our team. Willy’s extensive experience in quality management makes him a valuable problem-solving partner and effective project manager for MDR projects – also for your company!
The "Medical Device Single Audit Program" combines the requirements of ISO 13485: 2016 with the regulatory requirements of the participating countries (Canada, Brazil, Japan, Australia and the USA). A chance for international approvals and at the same time a challenge for your QM-System. We are ready! Ask us for a gap analysis.