MDSAP Country Specific Requirements (Japan)
Description:
In this course, we will focus on providing a detailed discussion of Japan’s Ministry of Health, Labour and Welfare (MHLW) and their country-specific requirements for the process chapters of MDSAP, as they were not covered in detail in the general MDSAP courses.
Curriculum for this course:
Introduction
Overview | 1 min 01 secs |
Learning Objectives | 54 secs |
Who Should Take This Program? | 1 min 04 secs |
Glossary | 1 min 10 secs |
MDSAP Basics | 1 min 14 secs |
MDSAP Audit Model | 1 min 09 secs |
MDSAP and Japan
Benefits of MDSAP to Japan | 1 min 05 sec |
Chapter 1 – Process: Management
Auditing the Management Process | 1 min 12 secs |
Audit Task 8 | 1 mins 29 secs |
Chapter 2 – Process: Device Marketing Authorization and Facility Registration
Auditing the Device Marketing Authorization and Facility Registration Process | 58 secs |
Audit Task 1 | 1 min 20 secs |
Audit Task 2 | 1 min 01secs |
Audit Task 3 | 1 min |
Chapter 3 – Process: Measurement, Analysis and Improvement
Auditing the Measurement, Analysis and Improvement Process | 1 min 21 secs |
Audit Task 7 | 1 min 02 secs |
Audit Task 12 | 1 min 10 secs |
Chapter 4 – Process: Medical Device Adverse Events and Advisory Notices Reporting
Auditing the Medical Device Adverse Events and Advisory Notices Reporting Process | 1 min 14 secs |
Audit Task 1 | 57 secs |
Audit Task 2 | 1 min 15 secs |
Chapter 5 – Process: Design and Development
Auditing the Design and Development Process | 1 min 01 secs |
Audit Task 1 | 49 secs |
Audit Task 13 | 1 min 05 secs |
Chapter 7 – Process: Purchasing
Auditing the Purchasing Process | 1 min 06 secs |
Audit Task 5 | 1 min 21 secs |
Conclusion
Final Assessment
Certification
Revision History
Course updated to v2.0 on 04/04/2023 to reflect FDA update to MDSAP Audit Approach policy document MDSAP AU P0002.008 including changes to: Audit sequence, management process, measurement analysis and improvement process, medical device adverse events and advisory notices reporting, design and development process and production and service controls | Version 2.0 |
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