Medical Device Single Audit Program (MDSAP) – Part 2


According to the Audit Model, the manufacturer must be able to map all processes, their links, and the ISO 13485 clause relating to them, and compare to the company processes and Standard Operating Procedures (SOPs), Quality Manual etc. This course will discuss this Audit Model further and the Best Industry Practices for organizing, training, and remediation of company processes and the quality management system.

Curriculum for this course:
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 3: Preparing for MDSAP Audit Process
Audit Criteria Built Into IMDRF Audit Model 1 min 05 sec
The MDSAP Audit and Preparation 1 min 15 se
Manufacturers Guide to prepare for MDSAP 55 secs
Where to Begin Preparation 1 min 30 sec
Preparing for MDSAP: Ensuring Consistency 1 min 23 s
Sterile Medical Device Requirements 1 min 15 sec
QMS: Deciding Which Processes Will Be Audited 1 min 30 secs
How to Prepare for MDSAP Audit Areas 1 min 10 secs
Preparing for MDSAP Audit: Training/Briefing 1 min 01 sec
MDSAP and Management Review 51 secs
Preparing for Audit: Gap Analysis 1 min 30 sec
Documents to Prepare 55 secs
Internal Audit-MDSAP Requirement 48 secs
QMS Assessment Checklist: Benchmarking/Internal Audit 1 min 15 sec
Internal Audits Plan Checklist 1 min 30 sec
The Compliance Matrix: A Valuable Tool 1 min 09 sec
Quality System Changes: ISO 13485:2016 and 21 CFR 820 1 min 28 sec
Preparing for the MDSAP: Conclusion 1 min 22 sec
Module 4: The MDSAP Audit
What’s Needed for Manufacturers Participation 1 min 12 secs
MDSAP Audit: General Information 1 min 55 secs
The “Model Audit” Document 1 min 02 secs
MDSAP Audit Scheduling 1 min 25 secs
Length of an MDSAP Audit 1 min 45 secs
Timing for Answers During Audit 1 min 38 secs
MDSAP Update on Audit Duration Adjustment 1 min 49 secs
Sterile Medical Device Manufacturers: MDSAP 1 min 39 secs
When are MDSAP Audits Conducted? 1 min 30 secs
The MDSAP Audits 1 min 01 secs
Stage 1: Initial Audit 58 secs
Stage 2: Evaluation of QMS Implementation and Effectiveness 50 secs
MDSAP : Surveillance Audit Timing 1 min 09 secs
Stage 3: Recertification Audit 1 min 18 secs
Audit Model: Special Audits and Short-Notice Audits 1 min 29 secs
Special Audits and “Recertification” Terms 1 min 05 secs
Audits Conducted by Regulatory Authorities 1 min 39 secs
Unannounced Audits 1 min 19 secs
Non-Conformities: MDSAP Grading 1 min 30 secs
Non-Conformities and Interrelationship 1 min 40 secs
The Audit and MDSAP Roles and Responsibilities 50 secs
Final Assessment

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