We are happy to announce that we were successfully audited for MDSAP:
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory jurisdictions of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. This certification is addition to being certified for ISO 13485:2016 and MDD.
The audit, conducted by 2 qualified auditors for the duration of 5 (five) days was very challenging and expensive. Very few companies in the global dental industry are holding such qualification. As always, Silmet will keep investing in being up to date with the ongoing regulatory changes in our industry.
With such a regulatory level of management, Silmet is in a position to become a long term partner for OEM & Co-Branding services. We have already signed several agreements with current OEM customers requesting the change to Co-Branding, as a result of the recent regulatory changes.
For further information please don’t hesitate to contact us.