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Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions. MDSAP requirements align with ISO 13485 along with supplemental QMS requirements in below major markets.

  • Australia
  • Brazil
  • Canada
  • Japan
  • United States

Audits are conducted by MDSAP recognized Auditing Organizations (AOs). AO will conduct an initial certification audit followed by annual surveillance audits every year. After three years, AO will conduct a recertification audit.

MDSAP Structure

MDSAP basically uses ISO 13485:2003 as a framework, in addition to good manufacturing practice (GMP) requirements of the various regulatory authorities. Auditors follow a structured and logical process approach, with links to other processes as clearly explained in the below attached MDSAP Companion Document. With the introduction of ISO 13485:2016, MDSAP will likely align to the new ISO 13485 standard.

The model includes seven processes:

(a) Primary processes

  • Management,
  • Measurement, Analysis, and Improvement,
  • Design and Development, and
  • Production and Service Controls

(b) Supporting processes

  • Purchasing,
  • Device Marketing Authorization and Facility Registration, and
  • Medical Device Events and Advisory Notices Reporting

What are the benefits of MDSAP certification?

  • Reduces multiple audits by Certification Bodies a manufacturer must undergo for multiple countries.
  • Efficient, single audit scheme minimizes business disruptions, reduces costs and saves time.
  • Faster market penetration where traditional regulatory oversight can cause significant delays.
  • Consistency of multiple, international regulatory programs by participating regulators.

Why choose I 3 CONSULTING?

We have trained MDSAP auditors to assess your quality system for MDSAP with exceptional technical expertise and experience in sector specifically qualified professional, effective and competent assessment of your systems.

  • Perform GAP analysis in line with ISO 13485:2003 / 2016 and the quality and regulatory requirements of Australia, Brazil, Canada, Japan & US.
  • Verify procedures, process, documentation, supporting objective evidence that the system is effective.
  • Evaluate control over critical suppliers and review adverse event reporting / recall / advisory notice information per country;
  • Prepare a written audit report of our findings.

Regulatory Authorities Participating in MDSAP

USA Flag Canada Flag Australia Flag Japan Flag Brazil Flag

United States of America [US FDA]
Canada, Health Canada
Australia, TGA
Japan, MHLW & PMDA
Brazil, ANVISA

Europe (EU) has only been participating in the MDSAP pilot as an observer, as there are concerns it would be difficult to obtain agreement among all member states. However, there is optimism the EU will join the program soon.

Our Consultation Fees

  1. GAP Assessment – 600 USD/Man-day without travel& Accommodation.
  2. Support for Fixing GAPS and process owner Interaction – 400 USD/Man-day without travel& Accommodation.
  3. Internal Audit -  600 USD/Man-day without travel& Accommodation.

Companion Document . Link >>>
Medical Device Single Audit Program Frequently Asked Questions

For more information and interested in taking our service, please write to us.

 

INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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GERMANY – Bremen
+49 2161 990 8831
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mail enquiry@i3cglobal.com
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