MDSAP

Medical Device Single Audit Program (MDSAP) – Part 1

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.

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CEU Credits: 0.1
Course Code: ELM-135
Duration: 45 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning objectives
Who should take this course?
Terms explained
Course modules
What is MDSAP?
International regulators: IMDRF
Parties involved in MDSAP and MDSAP pilot creation
International medical device regulators forum (IMDRF)
History of IMDRF
IMDRF and MDSAP requirements/documentation
The purpose of the MDSAP pilot
The MDSAP pilot timeline
The MDSAP timeline
MDSAP pilot program participating countries
International regulatory authorities participation
Observers of the MDSAP pilot and program
MDSAP - Roles of participants and observers
Pilot MDSAP “Criteria for Success”
How the MDSAP pilot audit was conducted
MDSAP pilot grading system
MDSAP Pilot: Mid-pilot status report
MDSAP Pilot: List of auditing organization participants
Expected improvements from implementing MDSAP pilot program audit model
Benefits of the “All-in-One” audit model
Manufacturers’ benefits of participating in MDSAP pilot
MDSAP pilot goals and future MDSAP use
MDSAP pilot audit model online
FDA site specific online information/forms
MDSAP online policies, procedures, templates and forms
MDSAP FDA and ANSA question and answer site
MDSAP document for audit assessment
MDSAP objective
About MDSAP objectives
MDSAP certificate
The MDSAP equals one audit for five countries
International participation and exclusions
MDSAP International and US participation
Manufacturers exceptions for inclusion in MDSAP: Electronic product radiation control
MDSAP audit plan has mapped requirements
MDSAP audit model structure
MDSAP Effectiveness: External factors
MDSAP impact on ISO 13485:2016
ISO 13485 versions
ISO 13485:2016 alignment with MDSAP
MDSAP audit general focus
The MDSAP audit-process approach
MDSAP Audit Roadmap: Seven process chapters
MDSAP sequence and interrelationships
Process Linkages (Interrelationships): audit model
MDSAP Audit Structure: Seven processes
Audit Model-FDA document P002 and companion document online

Conclusion

Final Assessment

Certification

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

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