US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW - MDSAP & EU ISO 13485 approach

This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach.

Why Should You Attend:

Companies conducting business in various geographical regions have to address numerous specific regulatory requirements from each of those geographies. This webinar will provide practical tools to address specific requirements from US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements from an unique Quality Management System (QMS) architecture ensuring compliance with those regulations.

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

Areas Covered in the Webinar:

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

Who Will Benefit:

• Quality Assurance Managers/Directors/VPs
• Regulatory Compliance Managers/Directors/VPs
• Regulatory Affairs Managers/Directors/VPs
• Clinical Managers/Directors/VPs
• Medical Device industries conducting or planning to conduct business in the European Union
• Free Materials:
• Reference documents