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