BSI is a fully recognized AO. We actively supported the MDSAP pilot and have been conducting audits since September 2014. Feedback about the benefits of MDSAP has been overwhelmingly positive.
BSI understands the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory clearance is key to maintaining a competitive edge.
We demonstrate this commitment through:
- Over 100 MDSAP assessors worldwide
- Over 280 QMS ISO 13485 assessors globally
- Over 2,050 years’ medical device product and regulatory experience
- Internal Product Experts and Auditors
- Direct access to your team of technical specialists