The ABC’s Of Medical Device Single Audit Program (MDSAP)

Webinar Type: On Demand
Duration: 40 Minutes
Zaher Kharboutly
Medical Devices Technical Manager
SAI Global

The Medical Device Single Audit Program (MDSAP) was created by the International Medical Device Regulators Forum (IMDRF) to enable audits that encompass ISO 13485 as well as the regulatory requirements from the United States, Canada, Australia, Brazil and Japan. The program offers many benefits, including an overall reduction in the number of audits and corresponding reduction in the disruptions to operations, increased confidence in audit preparedness, and a platform to expedite entry into global markets.

During this webinar we’ll discuss the key differences between MDSAP Audits and ISO 13485 QMS Audits, including:

  • How the MDSAP Scope audit is defined
  • How to prepare for the MDSAP
  • How to maximize your investment in MDSAP and introduce your products to new markets

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