- Module 1: Introduction to MDSAP
- What is MDSAP?
- Purpose and benefits of MDSAP
- Role of IMDRF in development of MDSAP
- MDSAP Members, Official Observers and Affiliate Members
- Relationship with ISO 13485 2016 and regulatory requirements
- MDSAP Guidance Documents
- Module 2: MDSAP Audit
- MDSAP Structure
- Audit Sequence
- MDSAP Audit Cycle
- Special and Unannounced Audits
- Audit Time and Duration
- Introduction to MDSAP NC Grading
- Module 3: MDSAP Requirements - Chapter 1 and 2
- Introduction to Chapter 1 and 2
- Chapter 1 Management Tasks 1-11
- Additional Country Specific Requirements
- Chapter 2 Tasks 1-3
- Additional Country Specific Requirements
- Module 4: MDSAP Requirements - Chapter 3 and 4
- Introduction to Chapter 3 and 4
- Chapter 3 Tasks 1-16
- Additional Country Specific Requirements
- Chapter 4 Tasks 1-2
- Additional Country Specific Requirements
- Module 5: MDSAP Requirements - Chapter 5
- Introduction to Chapter 5
- Project selection and planning
- Design and development inputs
- Verification, validation, clinical evaluation
- Design change, review, and transfer
- Software design and development
- Module 6: MDSAP Requirements - Chapter 6
- 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
- Module 7: MDSAP Requirements - Chapter 7 and Annexes
- 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
Our Online MDSAP Training Course aims to provide learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations – and it can be completed anytime, anywhere (24/7).
On completion, successful Learners will have the knowledge needed 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 P0002.006
Who Should Attend?
This course would be targeted at:
- Quality assurance professionals
- Quality Engineers
- Research and design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
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)
Upon registering for this course, each Learner will have 90-days of eLearning access to complete the course, including final assessment.
Recommended Prior Learning
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
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.
Click here to read the full technology requirements.
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