Online MDSAP Training #separator_sa #site_title

MDSAP Requirements & Auditor Foundation Training | Exemplar Global Certified

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Online MDSAP Requirements & Audits Training that provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

Our 8hr eLearning course 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.

Subject Area
Medical Devices
8 Hours
USD $ 695.00  per person
Team Pricing
USD $ 2,780.00
Exemplar Global

This MDSAP Foundation Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere. It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.

Learning Objectives

On completion of this Online MDSAP Training, successful Learners will have the knowledge needed to:

  1. Explain the purpose and benefits of an MDSAP audit of a medical device quality management system
  2. Identify the countries that recognize MDSAP audits
  3. Explain the role of IMDRF and its members in the development of the MDSAP scheme
  4. Explain the relationship between MDSAP, ISO 13485 and the regulatory requirements of the MDSAP member countries
  5. Describe the MDSAP audit approach and the process for assessing conformity as described in MDSAP AU P0002.006

Course Content

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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

Entry Requirements

It is recommended that each Learner should have the following prior knowledge before completing this course:

Management Systems

  • 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.

Quality Management

  • The fundamental concepts and commonly used quality management terms and definitions

Assessment & Certification

Assessment Methodology

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


Exemplar Global certify our MDSAP Training. Successful completion will entitle each Learner to receive a digital Certificate of Completion.