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United StatesMDSAP 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.
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
Module 1 – Introduction to MDSAP (35mins)
- History and Purpose of MDSAP
- Structure and Scope of MDSAP
Module 2 – MDSAP Audits (125mins)
- 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
Module 3 – MDSAP Chapters 1 and 2 (95mins)
- 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! Jurisdictional Requirements
Case Study! Country-specific Requirements
Module 4 – MDSAP Chapters 3 and 4 (110mins)
- 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
Module 5 – Design and Development (95mins)
- 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
Module 6 – Production and Service Controls (125mins)
- 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
Module 7 – MDSAP Chapter 7 and Annexes (95mins)
- 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
Final Assessment (45mins)
- 30 MCQ-based eAssessment with 70% or higher required to achieve certification
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
59 global ratings
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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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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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