3 Ways MDSAP Improves Audit Effectiveness

What is the MDSAP program?
In Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) began development of a Medical Device Single Audit Program (MDSAP). MDSAP allows approved auditing organizations to conduct a single regulatory audit of a medical device manufacturer. This single audit expands the scope of the audit to previously unaudited areas of large organizations, standardizes a consistent auditing model, and replaces as many as five separate . It also satisfies the regulatory requirements of the authorities participating in the program – even ISO 13485:2016. MDSAP focuses on defined and linked processes and is based on requirements for risk management. The goals of MDSAP are:

  1. to improve audit effectiveness and the influence the audit can have on outcomes that improve patient safety, and
  2. to reduce the resource demands on both regulatory bodies and auditees in organizations having to comply with a variety of global standards and .