One Audit. Multiple Markets.
With the Medical Device Single Audit Program (MDSAP), you can meet the regulatory requirements of multiple major markets including Australia, Brazil, Canada, Japan, and the United States.
Why partner with BSI?
- Work with a recognized MDSAP Auditing Organization that you can trust
- Gain access to Australia, Brazil, Canada, Japan, and the US
- Seamlessly align MDSAP with your existing ISO 13485 QMS
- Benefit from guidance delivered by global regulatory specialists who understand your challenges
Access MDSAP Resources here
How BSI supports you:
- Seamless integration of your ISO 13485 to reduce disruption
- Deep regulatory expertise
- Proven support for both SMEs and global manufacturers
If you’re thinking about expanding your market access, talk to us to see how MDSAP can simplify your path to global markets.
Further guidance can be found on the BSI website.





