Mastering the Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program, or MDSAP, provides the advantage of meeting the diverse requirements of multiple regulatory agencies through a single audit, which can help save time, resources and expenses. MDSAP is recognized by regulators including the U.S. Food and Drug Administration (FDA), Health Canada (HC), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Brazil’s ANVISA and the Australian Therapeutic Goods Administration (TGA).

This consolidated audit process also helps medical device manufacturers gain clearer insights into their QMSs, enabling them to improve operational efficiencies and product quality.

ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes – is the internationally recognized standard for QMSs in the medical device industry and serves as the backbone for MDSAP compliance. Both MDSAP and ISO 13485 focus on supporting the safety and effectiveness of medical devices through robust quality management systems.

Attendees of this webinar will:

• Get an in-depth overview of MDSAP and how it works.
• Learn about the integration of MDSAP and ISO 13485 QMS.
• Review MDSAP benefits for ISO 13485-certified manufacturers.
• Gain insights about the MDSAP certification process.
• Understand the transfer process from other Auditing Organizations (AOs).

We look forward to seeing you at the webinar!

Speaker

Maurizio La Mura, engineering manager, Consumer, Medical and Information Technologies, UL Solutions