Event Details
40 hours
Combination lecture and individual/group exercises
Available virtually
The course is designed for medical device professionals responsible for conducting or implementing internal audits, supplier audits, or corporate audits.
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Please contact us if you are interested in private training for this workshop.
40 hours
Combination lecture and individual/group exercises
Available virtually
Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. This five-day training course is focused on international MDSAP and ISO 13485 compliant medical device requirements and auditing methods. Course participants will gain knowledge and skills to conduct audits of ISO 13485:2016 management system requirements in accordance with the new MDSAP Audit Model.
The course provides extensive practical training and hands-on exercises that will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements. During training participants will learn to plan, conduct, report, and follow up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Auditing standards include MDSAP requirements, ISO 19011, and ISO 17021 (MDSAP auditors need to follow ISO 17021).
The course is designed for medical device professionals responsible for conducting or implementing internal audits, supplier audits, or corporate audits. Quality directors, regulatory managers, and professionals responsible for managing internal, corporate, supply chain or certification responsibilities may also benefit.
Through training, participants will learn to:
Day One
Introduction and Welcome
Chapter 1: MDSAP Background
Chapter 2: MDSAP Audit Structure
Chapter 3: Quality Management System
Written Exercise 1: Risk Management
Chapter 4: MDSAP Audit Model and Tasks
Management Processes
Device Marketing Authorization and Facility Registration
Measurement, Analysis and Improvement
Written Exercise 2a: Audit Scenarios
Day Two
Chapter 4: MDSAP Audit Model and Tasks (cont’d)
Medical Device Adverse Events & Advisory Notices Reporting
Design and Development
Production and Service Controls
Purchasing
Written Exercise 2b: Audit Scenarios
Understanding MDSAP Final Exam
Day Three
Chapter 5: Auditing using MDSAP Audit Model
Chapter 6: Audit Planning and Preparation
Breakout Exercise 1: Calculating Audit Duration
Breakout Exercise 2: Audit Objectives and Scope
Breakout Exercise 3: Preparing an Audit Plan
Breakout Exercise 4: Documentation Review
Day Four
Chapter 7: Audit Checklists
Chapter 8: Performing the MDSAP Audit
Chapter 9: Raising and Grading Nonconformities
Breakout Exercise 5: Raising and Grading Nonconformities
Day Five
Chapter 10: Leading Audit Teams
Chapter 11: Closing the Audit
Conduct MDSAP Mock Audit
MDSAP Lead Auditor Final Exam
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
Thanks for letting us know!
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