About
The MDSAP allows a recognized Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the requirements multiple regulatory authorities (RAs).
The MDSAP consortium is committed to protecting patient health and wellbeing by continuously improving our audit methodologies, fostering transparency, and upholding the integrity of medical device safety.
MDSAP was developed to encourage and support global harmonization of regulatory systems, where possible, to increase efficiency and reduce duplication of effort.
In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing an MDSAP.
This content is currently under development and will be published in 2025.
The MDSAP has three types of membership: RAC Member, Official Observer, Affiliate Member.
An AO is an organization that audits a medical device manufacturer for conformity with QMS requirements and other medical device regulatory requirements.