These are; Autralia, Brazil, Canada, Japan and United States. Audits are conducted by Auditing Organizations (AO), such as BSI, and authorized by MDSAP member Regulatory Authorities (RA). BSI is an Auditing Organization for MDSAP. Here at BSI, we also offer MDSAP in combination with CE, UKCA, ISO 13485 and ISO 9001 assessments. We have been active since MDSAP's inception pilot phase and have already completed a significant number of MDSAP audits, predominantly for world-leading medical device manufacturers and SMEs.
Medical Device Single Audit Program (MDSAP)
What is a Medical Device Single Audit Program audit?
MDSAP is based on a three-year audit cycle
Initial Audit: The Initial Certification Audit is a complete audit of a medical device manufacturers Quality Management System (QMS).
- Surveillance Audit - Year One.
- Surveillance Audit - Year Two.
- Re-Aduit (Re-Certification Audit) - Year Three.
BSI is a recognized AO providing QMS certification through MDSAP.
We are also a Conformity Assessment Body for EN ISO 17021-1 as accredited by the Dutch Accreditation Council & UK Accreditation Service. We offer:
Ensuring product development meets regulatory requirements is essential. At BSI, we provide training to support you through the application process.
Global Market Access
BSI Group Americas inc. is a recognised Auditing Organization
In addition to the 5 MDSAP member countries, the MDSAP affiliate members utilize the reports and certificates for market entry.
We can offer a seamless transfer service with comprehensive support and the absolute minimum level of disruption.
Which markets does MDSAP certification cover?
MDSAP is indicated for global manufacturers looking to export their medical devices into different countries participating in the program. These are:
Australia: The Therapeutics Goods AdministrationFind out more
Brazil: The Brazilian National Health Surveillance AgencyFind out more
Canada: Health CanadaFind out more
Japan: The Ministry of Health, Labour and Welfare, Pharmaceutical and Medical Devices AgencyFind out more
United States: U.S. Food and Drug Administration’s Centre for Devices and Radiological HealthFind out more
BSI and MDSAP: our commitment to excellence
We have been active since MDSAP inception pilot phase and have already completed a significant number of MDSAP audits, predominantly for world-leading medical device manufacturers and SMEs. Our commitment to trusted excellence includes:
• A global network of over 200 MDSAP assessors.
• More than 240 ISO 13485 QMS assessors worldwide.
• In-house Product experts and auditors.
• Access to a dedicated team of technical and clinical specialists.
How do I apply for MDSAP?
For clients holding ISO 13485, BSI can roll the MDSAP audit into the existing certification cycle. Contact us for more on how to apply for MDSAP.