Medical Device Single Audit Program (MDSAP) is a single audit of your QMS by a recognised certification body, that aims to ensure the requirements of multiple regulatory jurisdictions are satisfied. This program uses ISO 13485 as the framework adding the country-specific regulatory requirements. These requirements relate to market authorisation and registration, adverse event reporting etc. MDSAP does not take away from any product approval or registration requirements in each of the countries.
Countries currently part of Medical Device Single Audit Program (MDSAP) requirement are:
United States
Canada
Brazil
Australia
Japan
As experts, we specialise in guiding manufacturers to compliance whether it’s through ISO 13485: 2016 or with the additional requirements of MDSAP.
Our first logical step is always to perform a gap analysis.
