MDSAP Education Modules (CDRH Learn)

To inform the medical device manufacturing community about MDSAP, the U.S. Food and Drug Administration developed 10 medical device education modules. These modules are located on the USFDA’s CDRH Learn Program website under “Postmarket Activities Inspections – Global Harmonization”. Links to each module are also provided below

CDRH Learn Module Title	Key Learning Objectives
1A. Introduction to MDSAP Printable Slides   Transcript 1B. Overview of the MDSAP Audit Process Printable Slides   Transcript	Understand the purpose of the MDSAP program. Learn about the MDSAP audit model, sequence and process. Understand the requirements for writing nonconformity statements and the final report.
2. MDSAP Management Printable Slides   Transcript	Understand the purpose, audit tasks, expected audit outcomes and assessment of conformity for the management process. Learn about the links to other MDSAP processes. Recognize country specific requirements for the management process.
3. MDSAP Device Marketing Authorization and Facility Registration Printable Slides   Transcript	Understand the purpose, audit tasks and expected audit outcomes for device marketing authorization and facility registration. Learn about the links to other MDSAP processes. Recognize country specific requirements. Learn about the assessment of conformity for the Device Marketing Authorization and Facility Registration audit tasks.
4. MDSAP Measurement, Analysis and Improvement Printable Slides   Transcript	Printable Slides   Transcript Understand the purpose, audit tasks, expected audit outcomes and assessment of conformity for Measurement, Analysis and Improvement process. Learn about the links to other MDSAP processes. Recognize country specific requirements.
5. MDSAP Medical Device Adverse Events and Advisory Notices Reporting Printable Slides   Transcript	Understand the purpose, audit tasks and expected outcomes and links for Medical Device Adverse Events and Advisory Notices Reporting. Recognize country specific requirements. Learn about the assessment of conformity for the Medical Device Adverse Events and Advisory Notices Reporting audit tasks.
6. MDSAP Design and Development Printable Slides   Transcript	Understand the purpose and expected audit outcomes for the Design and Development process and the links to other MDSAP processes. Learn about the audit tasks and the assessment of conformity for the Design and Development process. Recognize country specific requirements.
7. MDSAP Production and Service Controls, Part 1 Printable Slides   Transcript	Understand the purpose of the Production and Service Control process. Learn the expected outcomes from the audit of the Production and Service Controls process. Learn about the audit tasks and links to other MDSAP processes. Recognize country specific requirements. Learn about the assessment of conformity for the Production and Service Control audit tasks.
8. MDSAP Production and Service Controls, Part 2 Printable Slides   Transcript	Understand the purpose of the Production and Service Control process. Learn the expected outcomes from the audit of the Production and Service Controls process. Learn about the audit tasks and links to other MDSAP processes. Recognize country specific requirements. Learn about the assessment of conformity for the Production and Service Control audit tasks.
9. MDSAP Production and Service Controls, Part 3 Printable Slides   Transcript	Understand the purpose of the Production and Service Control process. Learn the expected outcomes from the audit of the Production and Service Controls process. Learn about the audit tasks and links to other MDSAP processes. Recognize country specific requirements. Learn about the assessment of conformity for the Production and Service Control audit tasks.
10. MDSAP Purchasing Printable Slides Transcript	Understand the purpose, audit tasks, expected audit outcomes and conformity assessment for the Purchasing process. Learn about the links to other MDSAP processes. Recognize country specific requirements.