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 MDSAP 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 MDSAP 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, contact us to know more!

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