MDSAP Country Specific Requirements (Brazil)

Description:

In this course, we will focus on providing a detailed discussion of the Brazilian National Health Surveillance Agency (ANVISA) 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 10 secs
Learning Objectives 1 min 31 secs
Who Should Take This Program? 1 min 10 secs
Glossary 1 min 10 secs
MDSAP Basics 1 min 14 secs
MDSAP Audit Model 1 min 05 secs
MDSAP and Brazil 58 secs
Exclusions and ANVISA 30 secs
Chapter 1 – Process: Management
Auditing the Management Process 1 min 05 sec
Audit Task 6 1 min 10 secs
Audit Task 8 1 min 05 secs
Chapter 2 – Process: Device Marketing Authorization and Facility Registration
Auditing the Device Marketing Authorization and Facility Registration Process 1 min 12 secs
Audit Task 1 1 mins 29 secs
Audit Task 2 1 min 21 secs
Audit Task 3 1 min 25 secs
Chapter 3 – Process: Measurement, Analysis and Improvement
Auditing the Measurement, Analysis and Improvement Process 58 secs
Audit Task 1 1 min 20 secs
Audit Task 12 1 min 01 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 19 secs
Audit Task 1 1 min 02 secs
Audit Task 2 1 min 10 secs
Chapter 5 – Process: Design and Development
Auditing the Design and Development Process 1 min 14 secs
Audit Task 1 57 secs
Audit Task 8 1 min 15 secs
Audit Task 13 40 secs
Audit Task 16 55 secs
Chapter 6 – Process: Production and Service Controls
Auditing the Production and Service Controls Process 1 min 01 secs
Audit Task 4 49 secs
Audit Task 5 1 min 05 secs
Audit Task 6 1 min 09 secs
Audit Task 7 1 min 07 secs
Audit Task 16 1 min 02 secs
Audit Task 17 1 min 11 secs
Audit Task 21 49 secs
Audit Task 25 51 secs
Audit Task 27 56 secs
Chapter 7 – Process: Purchasing
Auditing the Purchasing Process 1 min 06 secs
Audit Task 8 54 secs
Audit Task 10 58 secs
Conclusion
Final Exam
Certification
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