I am excited to share that BrightInsight has achieved the Medical Device Single Audit Program (MDSAP) Certification, which 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 in a compliant manner.
MDSAP eliminates the need for country-specific audits of BrightInsight’s Quality Management System and design control documentation in participating countries, including the U.S., Canada, Japan, Brazil and Australia.
To achieve MDSAP certification, BrightInsight harmonized our ISO 13485:2016 certified Quality Management System to the MDSAP requirements, conducted employee trainings and provided updated design documentation.
MDSAP, or Medical Device Single Audit Program, is the 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.
You can learn more about our MDSAP certificate here.
Every line of our regulated BrightInsight Platform is built under a Quality Management System to support and optimize regulated drugs, devices and software through integrated data and actionable insights. The MDSAP certification adds to the list of internationally recognized certifications for BrightInsight, including:
If you are considering leveraging an unregulated software platform to support your digital health products, download our white paper on how using a regulated infrastructure reduces risk and ultimately accelerates your time to market.
As the de facto global regulated digital health platform for biopharma and medtech, BrightInsight will continue to achieve and maintain important quality, regulatory, security and privacy certifications.
I look forward to sharing more updates with you over the coming months.