Osseointegration International, an osseointegration (OI) implant manufacturer, announced that its processes have been certified by the Medical Device Single Audit Program (MDSAP). The program is aimed at enhancing the safety and quality oversight of medical devices on a global scale.
The MDSAP, part of the International Medical Device Regulators Forum, was created to streamline the auditing and monitoring of medical device quality management practices across international boundaries. The MDSAP allows accredited auditing organizations to conduct a single regulatory audit that fulfills the requirements of multiple regulatory authorities participating in the program.
Participation in the MDSAP involves collaboration with international partners, including regulatory authorities, and observing organizations from various countries. The US Food and Drug Administration is a member of the program, along with agencies in Australia, Brazil, Canada, and Japan.
“This certification marks a significant milestone for us,” said Munjed Al Muderis, the company’s founder. “It demonstrates our commitment to global excellence, innovation, and patient safety. By streamlining the auditing process and adhering to international standards, we can deliver in a way that meets the expectations of regulatory bodies and, more importantly, patients around the world.”
