Medical device single audit program (mdsap)

The Medical Device Single Audit Program aims at conducting a single regulatory audit of a medical device manufacturer in order to assess satisfaction of relevant requirements established by the participating regulatory authorities.

Being part of the MDSA Program provides benefits on a global scale, harmonising the criteria for the evaluation of the medical device and achieving certification and recognition in more than one markets; currently including Australia, Brazil, Canada, USA and Japan.

The integration of the SAP scheme offers the following benefits:

  • Reducing the time and the resources necessary to address audit findings, and especially in cases where there are overlaps
  • Minimising the number of regulatory audits required, contributing to fewer disruptions and lower costs
  • Incorporating ISO 13485 assessment requirements, including those applicable in the participating markets
  • Delivering access to a larger market, which benefits both patients and manufacturers

Medidee has a team of qualified consultants and auditors to help you preparing for an official MDSAP audit by performing an initial audit and coaching the pathway towards readiness.