MDSAP and EU ISO 13485 Approach – US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW

The MDSAP (Medical Device Single Audit Program) applies to all medical device manufacturers, wherein a recognized Auditing Organization can perform a single audit to ensure that regulatory authorities are satisfied with the results of the audit performed as per the guidelines of the regulatory authorities participating in the program.

MDSAP allows a device manufacturer to be audited once for the five geographies currently been listed: Australia, Brazil, Canada, Japan and the United States. Companies conducting business within these geographical regions have to address numerous specific regulatory requirements from each of those geographies. This webinar will provide practical tools to address specific requirements and EU ISO 13485:2016 requirements from a unique Quality Management System (QMS) architecture ensuring compliance with those regulations.

Areas Covered in the Session :
The webinar will discuss in detail how to address the gaps between US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements for:

• Management responsibilities
• Device marketing authorization
• Facility registration
• Measurement, analysis & improvement
• Adverse events & vigilance reporting
• Design and development
• Manufacturing and service controls
• Purchasing activities

Who Should Attend:

• Quality Assurance Managers / Directors / VPs
• Regulatory Compliance Managers / Directors /VPs
• Regulatory Affairs Managers / Directors / VPs
• Clinical Managers / Directors / VPs