TUV 13485 2x

Medical Device Single Audit Program (MDSAP)

Single regulatory audit of a medical device manufacturer to satisfy the relevant requirements of the regulatory authorities.

The International Medical Device Regulators Forum (IMDRF) External Link Disclaimer recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a working group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

To achieve MDSAP certification, manufacturers must modify their Quality Management System to meet MDSAP requirements, implement any changes, conduct employee trainings and provide updated design documentation.

BrightInsight’s MDSAP certification will enable us to accelerate time to market for our customer’s medical devices or Software as a Medical Device hosted on the BrightInsight Platform. MDSAP eliminates the need for country-specific audits in the participating countries, meaning that we can support our customers as they enter new markets more quickly and in a compliant manner.

More details about BrightInsight’s MDSAP certification:

BrightInsight’s Notified Body, TUV SUD, is an independent, non-governmental trusted partner of choice for safety, security and sustainability solutions.

Download the certificate here.



Back to Certifications