DUBLIN--(BUSINESS WIRE)--The "Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan: 2-Day In-Person Seminar" conference has been added to ResearchAndMarkets.com's offering.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.
One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan.
- The Medical Device Single Audit Program (MDSAP)
- Device Classification
- Licensing Pathways
- Medical Device GMP
- Device Labeling
- License Holder Responsibilities
- Timelines and Fees
- Country Specific Cultural Considerations and Challenges
- Adverse Event Reporting
Introduction and Agenda Review
Lecture 1: Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
Lecture 2: U.S. FDA Overview and Device Regulations
Lecture 3: Canada Medical Device Regulations
Lecture 4: Brazil Medical Device Regulations
Lecture 5: Australia Medical Device Regulations
Lecture 6: Japan Medical Device Regulations
Lecture 7: MDSAP Adverse Event Reporting / Common Themes
Lecture 8: Regulatory Process / Working with Global Agencies
Final Questions and Closure
For more information about this conference visit https://www.researchandmarkets.com/research/46j5ct/_medical_device?w=4