NEWS

Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP^* accreditation on the new ISO 13485:2016 Certificate.

The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical device manufacturers who market their products in Australia, Brazil, Canada, Japan and/or the United States. With MDSAP, a single regulatory audit conducted by an MDSAP recognized auditing organisation will satisfy the requirements of multiple regulatory authorities.

Among other benefits, the compliance of the quality management system with the requirements of this program allows harmonization of audit requirements, universal audit reporting and better knowledge of international regulatory requirements. This new certificate is also mandatory in 2019 to maintain or apply medical device licenses on the Canadian market.

Biomatlante is now part of the very restrictive club of MDSAP accredited organizations.

We pride ourselves to constantly work on improving our quality management system in order to provide medical devices that consistently meet customer demand and applicable regulatory requirements. MDSAP represents a new step in this continuous effort.

The new certificate also validates the ISO 13485 version 2016 and shows our willingness to make a successful transition to the new Medical Device Regulation (MDR) 2017/745/CEE.

*Medical Device Single Audit Program