BSI is a fully recognized AO. We fully supported the MDSAP pilot and have been conducting audits since September 2014. We’ve experienced increased interest and applications by manufacturers during 2015, 2016 and 2017. Feedback about the benefits of MDSAP has been overwhelmingly positive.
BSI understands the specific challenges medical device manufacturers face and the importance of bringinginnovative 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 240 QMS ISO 13485 assessors globally
- Over 2,050 years’ medical device product and regulatoryexperience
- Internal Product Experts and Auditors
- Direct access to your team of technical specialists