Medical Device Single Audit Program: Are you prepared for the MDSAP?
The Medical Device Single Audit Program (MDSAP) is an international initiative led by
Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can
conduct a single audit of a medical device manufacturer that would be accepted by
multiple regulators to address QMS and regulatory requirements.
The objectives of the MDSAP program are:
- Develop, manage, and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions
- To promote greater alignment of regulatory approaches and technical requirements
- To promote consistency, predictability, and transparency of regulatory programs
BSI has been authorized as an AO under the Medical Device Single Audit Program. This
allows BSI to conduct a single audit to assess manufacturers against the requirements of
all participating Regulatory Authorities, currently including: Australia, Brazil,
Canada, Japan and the USA.
From January 2019, Health Canada will only accept MDSAP certificates, which will replace
the current CMDCAS requirement.
This free BSI webinar will cover:
- What is MDSAP
- How MDSAP Works
- How does MDSAP fit with other certifications
- MDSAP Status
- Next Steps.
Patricia L. Murphy is the Global MDSAP Manager, at BSI, with
responsibility for all aspects of the Medical Device Single Audit Program. Patty will be
responsible for maintaining BSI's leadership role as the MDSAP program moves from
the Pilot Phase into the Operational Phase. This will be accomplished by continuing to
develop the competence of our assessment staff to meet the needs of our customers.