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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.
What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
This course is an internationally accredited credential. The Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants and RAPS credits for members.
Overview of our MDSAP Requirements Training
What's covered on our MDSAP Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- History and Purpose of MDSAP
- Structure and Scope of MDSAP
- 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! Jurisdictional Requirements
Case Study! Country-specific Requirements
- 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
Michelle Keane
Eoin Philip Kelly
On completion of this course, successful Learners will have the practical knowledge and be able to:
- 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
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (12).
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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What Our Learners Are Saying
4.5
Average Rating
145 global ratings
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Clear and concise, well paced.
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Great to be able to stop and start and go back. Great with the interactive parts showing up regularly
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Very good, well organized.
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Good course, very informative. I enjoyed learning this way.
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The course is extremely informative and provided a lot of good information. The information itself was explained in a way that was easy to understand and the knowledge checks really challenge your learning in a way that forces you to pay attention. Which I actually really liked.
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