We can help your company apply for the MDSAP program, by performing focused gap analysis and prepare your quality system for the audit program.


TSQ & E Asia can help client’s businesses opting for the MDSAP program, by doing gap analysis and making the client’s quality system ready for the audit program.

The International Medical Device Regulators Forum (IMDRF) formulated a working group to establish set of requirements as reference document for auditing organizations (Certification Bodies) conducting regulatory audits of Medical Device manufacturers’ QMS – quality management systems.

MDSAP is a means that medical device producers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Brazil, Australia, Japan, Canada and the United States.

Goals of MDSAP

The program’s goals include:

  • Preparation of an international association to increase medical device safety and avoid misunderstanding on a global level.
  • Formation of a single audit program that delivers confidence to international regulators
  • A reduced regulatory load on the medical device industry.
  • Allowing  government and regulatory authorities to emphasize on critical/problematic manufacturers, permitting notified bodies to perform inspections on their behalf.
  • More effective and less troublesome regulatory misunderstanding of medical device manufacturers’ quality management systems.
  • More effective implementation of regulatory means through work-sharing and mutual acceptance among regulators.
  • Improved global alignment of regulatory methods, and technical necessities based on harmonized standards and best practices.

The Medical Device Single Audit Program enables an MDSAP recognized Auditing Organization to carry out a single regulatory audit of a medical device producing company that meets the applicable requirements of the regulatory authorities going in the program.


What are the advantages of MDSAP?

It is a Single Audit by Auditing Organizations would:

  • Minimize interruptions in operations of medical device producing company due to multiple regulatory audits.
  • Provide foreseeable audit schedules (agenda with opening and completion dates).
  • Benefit patient health and patient access with entrance ease to numerous markets
  • Leverage and enhance regulatory resources
  • Incorporate and add ISO 13485 review assessment
  • Requirements, together with Australia, Brazil, Canada, Japan and US
  • Minimization in time and resource coping up with findings from multiple audits
  • Minimization in the cost of audits in related to independent audits
  • Improved transparencies in the medical device industry

Contact TS Q&E Asia for more information.

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