Team Lead, Quality and Regulatory Affairs
The Medical Device Single Audit Program (MDSAP) has been developed by International Medical Device Regulators Forum (IMDRF).
Australia, Brazil, Canada, Japan, and the USA all participate in the MDSAP.
MDSAP allows an MDSAP Recognized Auditing Organisation to conduct a single regulatory audit of a medical device manufacturer
that satisfies the relevant requirements of the regulatory authorities participating in the program.
Canada accepts only MDSAP quality management system certificates in the medical device licence applications.
✔ If you want to evaluate the readiness of your quality management system for an MDSAP audit, Labquality can conduct an MDSAP mock audit for you.
MDSAP mock audits follow the tasks described in the MDSAP Audit Approach, which is based on the requirements of ISO 13485:2015 standard and
contains the additional requirements of MDSAP countries.