Medical Device Single Audit Program (MDSAP) – Part 1

Description:

This course will examine the process of preparing and applying for the Medical Device Single Audit Program (MDSAP). It is written from the perspective of the Medical Device company that is considering joining or in the process of joining the program. In addition, an overview of the MDSAP program will be provided, as well as links to more in-depth information on certain topics.

Curriculum for this course:
Introduction
Overview 45 secs
Learning objectives 1 min
Who should take this course? 30 secs
Terms explained 1 min 15 secs
Course modules 35 sec
Module 1: Introduction to MDSAP
What is MDSAP? 43 secs
International regulators: IMDRF 55 secs
Parties involved in MDSAP and MDSAP pilot creation 48 secs
International medical device regulators forum (IMDRF) 49 secs
History of IMDRF 51 secs
IMDRF and MDSAP requirements/documentation 1 min 02 secs
The purpose of the MDSAP pilot 1 min 10 secs
The MDSAP pilot timeline 58 secs
The MDSAP timeline 44 secs
MDSAP pilot program participating countries 39 secs
International regulatory authorities participation 50 secs
Observers of the MDSAP pilot and program 1 min 01 sec
MDSAP – Roles of participants and observers 57 secs
Pilot MDSAP “Criteria for Success” 1 min 10 secs
How the MDSAP pilot audit was conducted 51 secs
MDSAP pilot grading system 39 secs
MDSAP Pilot: Mid-pilot status report 45 secs
MDSAP Pilot: List of auditing organization participants 1 min 30 secs
Expected improvements from implementing MDSAP pilot program audit model 1 min 07 secs
Benefits of the “All-in-One” audit model 59 secs
Manufacturers’ benefits of participating in MDSAP pilot 1 min 22 secs
MDSAP pilot goals and future MDSAP use 43 secs
MDSAP pilot audit model online 1 min 11 secs
FDA site specific online information/forms 55 secs
MDSAP online policies, procedures, templates and forms 1 min 15 secs
MDSAP FDA and ANSA question and answer site 50 secs
MDSAP document for audit assessment 1 min 10 secs
Module 2: The MDSAP Audit Model Overview
MDSAP objective 1 min 09 sec
About MDSAP objectives 58 secs
MDSAP certificate 59 secs
The MDSAP equals one audit for five countries 1 min 05 sec
International participation and exclusions 49 secs
MDSAP International and US participation 1 min 15 sec
Manufacturers exceptions for inclusion in MDSAP: Electronic product radiation control 51 secs
MDSAP audit plan has mapped requirements 1 min 23 sec
MDSAP audit model structure 48 secs
MDSAP Effectiveness: External factors 55 secs
MDSAP impact on ISO 13485:2016 1 min 10 sec
ISO 13485 versions 55 secs
ISO 13485:2016 alignment with MDSAP 59 secs
MDSAP audit general focus 55 secs
The MDSAP audit-process approach 1 min 30 sec
MDSAP Audit Roadmap: Seven process chapters 1 min 15 sec
MDSAP sequence and interrelationships 1 min 18 sec
Process Linkages (Interrelationships): audit model 1 min 23 sec
MDSAP Audit Structure: Seven processes 1 min 55 sec
Audit Model-FDA document P002 and companion document online 48 secs
Conclusion
Final Assessment
Certification
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