MDSAP Auditor Foundation Training 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.
Course Overview
MDSAP Auditor Foundation 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 P0002.006
A summary of learning topics within this course include:
- What is MDSAP?
- Purpose and benefits of MDSAP
- Role of IMDRF in the development of MDSAP
- MDSAP Members, Official Observers, and Affiliate Members
- Relationship with ISO 13485 2016 and regulatory requirements
- MDSAP Guidance Documents
- MDSAP Structure
- Audit Sequence
- MDSAP Audit Cycle
- Special and Unannounced Audits
- Audit Time and Duration
- Introduction to MDSAP NC Grading
- Introduction to Chapters 1 and 2
- Chapter 1 Management Tasks 1-11
- Additional Country-Specific Requirements
- Chapter 2 Tasks 1-3
- Additional Country-Specific Requirements
- Introduction to Chapters 3 and 4
- Chapter 3 Tasks 1-16
- Additional Country-Specific Requirements
- Chapter 4 Tasks 1-2
- Additional Country-Specific Requirements
- Introduction to Chapter 5
- Project selection and planning
- Design and development inputs
- Verification, validation, and clinical evaluation
- Design change, review, and transfer
- Software design and development
- Introduction to Chapter 6
- Tasks 1-9 including country-specific requirements
- Tasks 10-19 including country-specific requirements
- Tasks 20-29 including country-specific requirements
- Introduction to Chapter 7
- Tasks 1-6 including country-specific requirements
- Tasks 7-12 including country-specific requirements
- Annex 1 and Annex 2
- Annex 3 Adverse Events and Advisory Notices Reporting
- Annex 4 Written Agreements
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 & Auditor Foundation 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) within the 90-day course license
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
50 global ratings
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The course was well paced and informative.
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Thought it was good and educational. User friendly.
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Nice user interface. Easy to use. Will recommend this site to associates who are looking for training solutions, refresher courses, etc.
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I learned allot excellent training.
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Other than the feedback previously provided, this training was well organized and clear. Links to the available supplementary content was useful.
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