Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan 2018

Topics

• Device Classification
• The Medical Device Single Audit Program (MDSAP)
• Medical Device GMP
• Licensing Pathways
• Device Labeling
• Inspections
• Timelines and Fees
• License Holder Responsibilities
• Adverse Event Reporting
• Country Specific Cultural Considerations and Challenges

Who should Attend

Attendees from:

• Quality assurance, quality control, and quality systems
• Regulatory Affairs
• Contract research organizations
• Product development personnel
• Site managers
• Business management
• Contractors and subcontractors
• Senior and executive management
• Consultants
• Distributors