New White Paper:
Why Implement the Medical Device Single Audit Program (MDSAP)?

 


MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to address the ongoing and rapid healthcare technology innovations that resulted in more sophisticated medical devices requiring greater regulator expertise to place into global markets and monitor over time.

MDSAP also addresses the exploding global trade in the medical device sector. Currently five jurisdictions make up the MDSAP consortium. They include Australia, Brazil, Canada, Japan and the United States.

The ongoing pandemic continues to present new challenges for medical device businesses with respect to manufacturing, procuring and/or distributing critical medical products and components and for expanding healthcare systems around the world.

MDSAP integrates not only the requirements of ISO 13485, but adds in the Regulatory requirements of the five participating countries. Also, MDSAP is especially designed for organizations operating with multiple sites and in multiple markets. MDSAP represents more complexity, more audit time and utilizes a highly structured audit model. SAI Global has put together a readiness checklist that will allow organizations to prepare with confidence and optimize the investment of an MDSAP certification program to ensure a robust QMS, successful audit and ultimately, certification.

 

 

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