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United StatesMDSAP Requirements for Practitioners and Auditors
MDSAP Requirements Training for Practitioners and Auditors that provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach. This course has been specifically designed for those who are new to MDSAP.
Our online training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
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Course Structure Explained
eLearning Module Breakdown & Timings
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
| Time | Topic |
|---|---|
| 35mins eLearning | Module 1 – Introduction to MDSAP
|
| 125mins eLearning | Module 2 – MDSAP Audits
Case Study! Role of the Australian Sponsor Case Study! Audit Time Determination |
| 95mins eLearning | Module 3 – MDSAP Chapters 1 and 2
Case Study! Jurisdictional Requirements Case Study! Country-specific Requirements |
| 110mins eLearning | Module 4 – MDSAP Chapters 3 and 4
Case Study! Data Sources, Preventative Action, Verification of Effectiveness and Management Representative Case Study! Process Change and Regulatory Impact Case Study! Adverse Event Reporting |
| 95mins eLearning | Module 5 – Design and Development
Case Study! Outsourced Design and Development Case Study! Software and Hardware Change |
| 125mins eLearning | Module 6 – Production and Service Controls
Case Study! Training and Documentation Case Study! Medical Device File Case Study! Control of Cleanliness of Product Case Study! Software Validation |
| 95mins eLearning | Module 7 – MDSAP Chapter 7 and Annexes
Case Study! Technical Documentation Case Study! Customer vs Supplier vs Outsourcing |
| 40mins | Certification Exam
|
Course Overview
MDSAP Requirements Training
Explain the purpose and benefits of an MDSAP audit of a medical device quality management system
Identify the countries that recognize MDSAP audits
Explain the role of IMDRF and its members in the development of the MDSAP scheme
Explain the relationship between MDSAP, ISO 13485, and the regulatory requirements of the MDSAP member countries
Describe the MDSAP audit approach and the process for assessing conformity as described in MDSAP AU P0002
This course would be targeted at:
- Quality assurance professionals
- Quality Engineers
- Research and Design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
Exemplar Global certifies our MDSAP Requirements Training. Successful completion will entitle each Learner to receive a digital Certificate of Completion.
It is recommended that each Learner should have the following prior knowledge before completing this course:
- The Plan, Do, Check, Act (PDCA) cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
- The fundamental concepts and commonly used quality management terms and definitions
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our 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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Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.5
Average Rating
64 global ratings
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Excellent training. A lot covered over 1 day.
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Trainer was very knowledgeable and open to answering questions throughout the training. the trainer gave very good information to support the requirements of Clinical evaluation Reports.
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Very good foundation course.
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Very pleased with the quality and thoroughness of this course, the pace is 100% controlled by the attendee so ideal to work it into a busy schedule, the visuals are well done with key elements highlighted. Perfect for all quality and supporting personnel. Very very pleased with this course!
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The course was well paced and informative.
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