Medical Device Single Audit Program (MDSAP) certification applies to the United States, Canada, Australia, Brazil, and Japan.
CHICAGO/March 15, 2023 – Jointechlabs, Inc., a privately held US-based regenerative medicine and therapeutics company, today announced it has been granted an MDSAP certification for its quality management system that satisfies the requirements of multiple regulatory jurisdictions. These jurisdictions include the United States, Canada, Australia, Brazil, and Japan.
The MDSAP allows medical device manufacturers to be audited once for compliance with multiple jurisdictions’ standards and regulatory requirements. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”
To earn this certification, Jointechlabs underwent a comprehensive audit by a regulatory body. The company demonstrated that its quality management and manufacturing systems conform to the exacting standards of ISO 13485:2016. ISO 13485:2016 is the most recent and rigorous 13485 standard for medical device manufacturers. The requirements cover quality systems, management, and the entire medical device product journey from conceptualization to implementation. Additionally, customer support, event reporting, continuous improvement, and regular product evaluation are components.
“We are thrilled and honored to earn this MDSAP quality certification,” said Dr. Nishit Pancholi, COO of Jointechlabs. “Quality is a core company value and one of the things that set us apart. Moreover, producing the purest, highest quality biologics allows our customers to achieve the best outcome at the lowest risk.”
The MDSAP certification is not mandatory for medical device manufacturers. There is no publicly available listing of companies who are MDSAP certified. However, companies who earn the certification generally make their status known.
More information from the US F.D.A. is available at https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap