CERSI Lecture Series

Science and Research at FDA

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.

LEARN


 

Medical Device Single Audit Program (MDSAP)

Slide 1

 

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 Closed Captioned   Printable Slides   Transcript

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


 

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