Are you a medical device manufacturer operating internationally? The Medical Device Single Audit Program (MDSAP) may simplify and streamline your QMS global compliance.
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows a single audit of your Quality Management System (QMS) that meets the regulatory requirements of up to five countries: Australia, Brazil, Canada, Japan, and the United States.
Audits are performed by authorised Auditing Organizations (AOs), such as BSI, recognised by Regulatory Authorities (RAs).
What does the audit process look like?
MDSAP is based on a three-year audit cycle:
- Initial Audit - Full certification audit of the manufacturer’s QMS
- Surveillance Audit – Year 1
- Surveillance Audit – Year 2
- Re-audit – Year 3
What are the benefits of MDSAP?
- One audit, multiple markets – meet requirements in five countries with a single audit
- Reduced regulatory burden – avoid multiple, overlapping audits
- Faster global access – streamline your path to market entry
- Supports continuous improvement – helps you proactively address compliance gaps
- Enhances reputation – demonstrates strong quality and safety commitment
Why choose BSI?
BSI Group Americas Inc. is a recognised Auditing Organization for MDSAP. It’s been active since the pilot phase and have delivered hundreds of audits for global medical device manufacturers and SMEs.
What we offer:
- A global network of 200+ MDSAP assessors
- In-house technical and clinical experts
- Seamless integration with CE marking, UKCA, ISO 13485, and ISO 9001 audits
Need help getting started?
BSI can support you through every step of your MDSAP journey, from preparation to certification and beyond. We also offer training, webinars, and expert guidance.
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