MDSAP Auditor Training
MDSAP Auditor Training that provides learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations.
Our blended learning course is a hybrid approach where learners first complete eLearning modules on the underlying theory that better prepares learners in advance of attending Live Classes with an experienced Instructor. Our live workshops are based on practical training methods with real-world examples, case studies, facilitated exercises and group discussions.
CQI and IRCA certify this course (No. 2694) offering global recognition for successful participants.
Overview of our MDSAP Auditor Training
Upcoming Dates for MDSAP Auditor Training
Register 3 + Get 1 Free
What's covered on our MDSAP Auditor Training
Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.
- History and Purpose of MDSAP
- Structure and Scope of MDSAP
Module 2 – MDSAP Audits
- Structure, Scope, and Sequence
- Audit Cycle, Special and Unannounced Audits
- Audit Time and Duration
- Non-Conformity Grading
- Reporting
Case Study! Role of the Australian Sponsor
Case Study! Audit Time Determination
- Chapter 1 Introduction
- Management Process Structure
- What Auditors Look For (Chapter 1)
- Jurisdictional Requirements
- Chapter 2 Introduction
- Process Structure
- Country-specific Requirements
- What Auditors Look For (Chapter 2)
Case Study! Management Responsibility
Case Study! Purchasing Controls
- Chapter 3 Introduction
- Basis of Measurement, Analysis, Improvement (MAI)
- Non-conforming Product Control
- MAI and Internal Audits
- What Auditors Look For (Chapter 3)
- Chapter 4 Introduction
- Overview of Task 1
- Overview of Task 2
Case Study! Data Sources, Preventative Action, Verification of Effectiveness and Management Representative
Case Study! Process Change and Regulatory Impact
Case Study! Adverse Event Reporting
- Introduction to Design and Development (D&D)
- Audit Approach
- Planning
- Process
- Design Transfer
- Risk Management
- Software
- Change Management
Case Study! Outsourced Design and Development
Case Study! Software and Hardware Change
- Introduction to Task 6
- Tasks and Linkages 1 to 10
- Tasks and Linkages 11 to 20
- Tasks and Linkages 21 to 29
Case Study! Training and Documentation
Case Study! Medical Device File
Case Study! Control of Cleanliness of Product
Case Study! Software Validation
- Introduction to Chapter 7
- Purchasing Tasks Overview
- Purchasing Tasks 1 to 4
- Purchasing Tasks 5 to 9
- Purchasing Tasks 10 to 12
- Additional Jurisdictional Requirements
- The Annexes
Case Study! Technical Documentation
Case Study! Customer vs Supplier vs Outsourcing
- Welcome and Overview
- Recap of Audit Objectives, Scope, and Criteria
- Overview of the MDSAP Audit Sequence and Process-based Structure
Practical Workshop MDSAP Certification Lifecycle
Practical Workshop Documentation Review – Audit Plan
- Review of Key Documentation
- Preparation of a process-based audit plan aligned with the MDSAP Audit Model
Practical Workshop Audit Plan, Continued
Practical Workshop Audit Checklist
- Development of audit checklist mapped to MDSAP tasks and regulatory authority expectations
- Emphasis on risk-based prioritization
Practical Workshop Audit Checklist (Continued)
- Finalizing Checklist Content
- Planning and conducting the opening meeting in line with MDSAP expectations and best practices
Practical Workshop Opening Meeting
Practical Workshop Simulated Case Study
- Simulated audit case study – Initiating audit execution phase using the MDSAP model
Practical Workshop Generating Audit Findings
- Conducting audit interviews
- Gathering and evaluating objective evidence
- Generating and grading findings based on MDSAP nonconformity criteria
Practical Workshop Generating Audit Findings (Continued)
- Writing clear, evidence-based findings
- Referencing applicable MDSAP tasks and regulatory requirements
- Developing the audit report structure
Practical Workshop Closing Meeting, Audit Report & Follow-Up
- Finalizing the audit report
- Conducting the closing meeting
- Evaluating corrective action plans and post-audit follow-up activities
- Q&A
- Course Wrap-Up
Michelle Keane
Eoin Philip Kelly
- Explain the purpose of a medical device single audit program (MDSAP) medical device quality management system audit process in the context of ISO 13485 and regulatory compliance.
- Explain the role and responsibilities of an auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 17021, regulatory body requirements and the MDSAP audit criteria.
- Plan for and conduct an audit of a medical device quality management system, report, and grade non-conformities to establish compliance with ISO 13485 and regulatory requirements using MDSAP methodology.
CQI & IRCA certify this course (No. 2694). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
Prior to attending this course, learners are expected to have the following prior knowledge:
ISO 13485
- Knowledge of the ISO 13485 Requirements
- Must have successfully completed a CQI and IRCA Certified MD-QMS ISO 13485 Internal or Lead Auditor course or equivalent.
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
- The process approach used in quality management.
- A working knowledge of risk-management principles related to the design of a medical device, through ISO 14971.
To successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for.
- Fully attend the Instructor Workshops as 100% attendance is required.
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
For the live workshops during a virtual delivery, we utilize Microsoft Teams and SharePoint.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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Frequently Asked Questions
Blended learning is a hybrid methodology where learners first complete eLearning modules on the underlying theory in advance of Live Workshops facilitated by an experienced Instructor.
This introduces more flexibility vs traditional learning by reducing ‘fixed’ classroom hours by up to 50%. In addition, improved learner confidence & preparation from the eLearning leads to better learning outcomes during the skills-based workshops.
Yes, very practical. Our live workshops are based on the principles of Accelerated Learning (AL). AL is based on ‘learn by doing’ through practical training methods which include real-world examples, case studies, facilitated exercises and group discussions.
We are passionate about ‘No Death by PowerPoint’ or a ‘sit and listen’ methodology. In fact, there are no slides during the live workshops. Come prepared to be fully engaged and of course, to learn a lot!
Yes, we can deliver training in-person or onsite for in-company groups. However, all our public training is delivered virtually. If you prefer in-person training, get in touch, we are happy to help.
Yes, we offer in-company training provided you have 5 or more learners that can be trained together on the same dates. Please request a quote and a member of our team will be in touch to discuss this further with you.
The eLearning unlocks up to 30 days in advance of the scheduled workshop(s). This is intentional. The modules are designed for learning to be achieved in the weeks leading up to live workshop(s) to ensure continuity in learning.
Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
Please note: no certificates are available without full payment on file.
Yes, we permit substitutions provided the license has not been activated, the substitute meets the entry criteria and there is sufficient time available for the replacement to complete the mandatory eLearning and assessments. There is no fee for substitutions.
If the workshop is delivered virtually, there will be a link on your Learner dashboard. This link will become a visible two days in advance of the start date. In addition, a calendar invite is issued.
The eLearning modules, including assessments, form a mandatory part of the training. To be eligible to attend the live workshop(s), these must be successfully completed in advance of the specific deadline date for your registered workshops(s).
Note: if the eLearning modules and assessments are not successfully completed by the deadline, you will not be eligible to attend the live workshops. No refunds are possible when you fail to complete the eLearning on time.
Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.
Comply Guru do not provide learners with copies of international standards, nor do we require that any purchase is made. However, participants do need to have access to a copy of required standard(s) on this training.
Firstly, we suggest seeing if you can obtain a copy of the required standard(s) from a friend, colleague or at your workplace. If you are unable to do so, each country has a nominated ISO standard supplier where you may purchase the international standard(s) you need for your training.
The eLearning duration provided is an estimate based on the average amount of time it takes a learner who is new to the subject/topic. In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.
No, there is no end of course examination. However, you must attend 100% of the live workshops and obtain 70% or higher in graded exercises during the live workshops in order to receive certification.
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What Our Learners Are Saying
4.7
Average Rating
86 global ratings
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The course exceeded my expectations and make me fully prepared to apply the content immediately.
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I rate both the elearning materials and the workshop sessions very highly. The training materials were well prepared, the trainer was highly experienced and presented the topic in an engaging way, the group size was appropriate, and the exercises were interesting and relevant.
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highly insightful and practical MDSAP auditing approach training. Clear explanations of grading, timing and global nuances Canada, Brazil, Australia. Engaging delivery and real world examples made topics understandable &actionable. My trainer Michelle was extremely knowledgeable and welcoming.
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I love the dynamic of the training and the training instructor Michelle, was wonderful Very knowledgeable and easy to understand .
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The overall MDSAP virtual training experience was positive and worthwhile. Although the session was postponed for two days due to an unexpected IT issue, the situation was managed effectively. The content itself was clear, well structured.
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