A recent audit saw Hamilton Medical AG pass the initial certification according to the new, mandatory Medical Device Regulation (MDR) 2017/745.
Hamilton Medical is one of the first medical device companies to receive this important certification for the future.
The audit was carried out last week in Bonaduz and Ems by two auditors from the notified body TÜV Rheinland during 6 man days. Based on the outstanding result, they will recommend to the accreditation body that our existing certificates be extended and we be granted certification according to the new Medical Device Regulation.
This is a significant achievement in both respects, bearing in mind the importance of the CE Mark in allowing easy product registration and the sale of our devices within the EU markets, as well as in all those other countries accepting the CE Mark. Receiving Medical Device Regulation certification is another important cornerstone of our Quality Management System.
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