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MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.

ISO 13485 MDSAP are two different programs with similar requirements but they do not duplicate each other. MDSAP has the more stringent requirements of the two and companies that are already certified to ISO 13485 will see an increase in the number of audit days once they seek certification to MDSAP. What is MDSAP?

ISO 13485 MDSAP are two different programs with similar requirements but they do not duplicate each other. MDSAP has the more stringent requirements of the two and companies that are already certified to ISO 13485 will see an increase in the number of audit days once they seek certification to MDSAP. What is MDSAP?

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.

The MDSAP audit sequence follows a process approach and has four primary processes: (1) Management; (2) Measurement, Analysis and Improvement; (3) Design and Development; (4) Production and Service Controls; and a supporting process, (5) Purchasing.

The MDSAP audit sequence follows a process approach and has four primary processes: (1) Management; (2) Measurement, Analysis and Improvement; (3) Design and Development; (4) Production and Service Controls; and a supporting process, (5) Purchasing.

MDSAP Industry Benefits Higher efficiency and flexibility regarding the use of regulatory resources through work-sharing and mutual acceptance among regulators, while still respecting the jurisdictions of each authority.

An MDSAP audit uses a process approach, based on a foundation of risk management, to select samples of procedures and records to examine. The audit is focused on how risks are identified and addressed. The audit process is described in the MDSAP Audit Model.

MDSAP Industry Benefits Higher efficiency and flexibility regarding the use of regulatory resources through work-sharing and mutual acceptance among regulators, while still respecting the jurisdictions of each authority.

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.

The MDSAP functional statement defines the policy as, “To jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers' quality management systems.”.

FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities.

An MDSAP audit uses a process approach, based on a foundation of risk management, to select samples of procedures and records to examine. The audit is focused on how risks are identified and addressed. The audit process is described in the MDSAP Audit Model.

The MDSAP functional statement defines the policy as, “To jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers' quality management systems.”.

The MDSAP is voluntary in Australia, Brazil, Japan, and the United States.

FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities.

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.

The MDSAP functional statement defines the policy as, “To jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers' quality management systems.”.

FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities.