MDSAP Requirements for Practitioners and Auditors Training

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 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.