FDA CERSI Lecture Series, MDSAP Pilot
CERSI Lecture Series
WHAT: Lecture series to present current research and advancements in regulatory science related to pre-clinical evaluation of safety and efficacy of medical products, emerging technologies, and assessing diverse data sets through information sciences to improve health outcomes.
WHO: Centers of Excellence in Regulatory Science and Innovation
WHEN: CERSI Workshops & Meetings
HOW: Presented by scientists from the CERSI academic institutions or collaborators of CERSI investigators.
Medical Device Single Audit Program (MDSAP)
WHAT : Invitation to manufacturers to participate in innovative regulatory single audit program.
WHO: MDSAP Regulatory Authority Council
HOW: Learning modules in CDRH Learn – see links below
Inspections – Global Harmonization (New modules 9/8/16)
Primer – International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) Pilot
Presentation
1. Introduction to MDSAP
Presentation
2. MDSAP Management
Presentation
3. MDSAP Device Marketing Authorization and Facility Registration
Presentation
4. MDSAP Measurement, Analysis and Improvement
Presentation
5. MDSAP Medical Device Adverse Events and Advisory Notices Reporting
Presentation
6. MDSAP Design and Development
Presentation
7. MDSAP Production and Service Controls, part 1
Presentation
8. MDSAP Production and Service Controls, part 2
Presentation
9. MDSAP Production and Service Controls, part 3
Presentation
10. MDSAP Purchasing
Presentation