ISO 13485:2016, MDSAP Requirements and Regulatory Transitions

ISO 13485 is the international standard that defines quality management system requirements for organizations involved in one or more stages of the medical device product lifecycle. This includes design and development, production, storage and distribution, installation or servicing of a medical device. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services.

The Medical Device Single Audit Program (MDSAP) audit process was designed to provide a single audit that covers regulatory requirements of medical devices – quality management systems and regulatory purposes (ISO 13485), as well as the specific requirements of medical device regulatory authorities participating in the MDSAP (Australia, Brazil, Canada, Japan, and the US Quality System Regulation). 

This course offers practical instruction on both ISO 13485:2016 and MDSAP, preparing you and your organization for the challenges of implanting these requirements and preparing for successful audit outcomes associated with these standards and policies.

Registration fee includes:

• All training materials
• Resource material
• ISO 13485:2016 Medical Device QMS Standard (hard copy)
• Lunch daily

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