Lancer Orthodontics is pleased to announce it has earned the coveted MDSAP certification from its Notified Body, BSI.
The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit to be conducted of a medical device manufacturer’s quality management system for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
While Canada is the earliest adopter of MDSAP as a nationwide standard of certification, the US and other countries are expected to adopt MDSAP as the gold standard of medical device certification. With this important certification now secured, Lancer is poised to capture new and previously unavailable territories which require MDSAP certification.
Lancer is firmly dedicated to incorporating the strict global requirements that govern the manufacture of medical devices into the daily operations of its quality management system. MDSAP certification is the next step in ensuring Lancer’s global regulatory compliance, leading to a continuously growing base of satisfied customers around the world.