MDSAP Requirements & Auditor Foundation Training | Exemplar Global Certified
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.
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:
- 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
Course Content
<insert here>
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
Certification
Exemplar Global certify our MDSAP Training. Successful completion will entitle each Learner to receive a digital Certificate of Completion.
Reviews & Ratings
4.7
Average Rating
21 global ratings
-
Comply Guru course was very informative and clear!
-
The MDSAP course was comprehensive and had the right level of difficulty. The mix of education modules, slides, training videos, and tests made it engaging and worthwhile. Highly recommendable!
-
Great course to get the basic foundation and introduction of the MDSAP audit program.
-
I was surprised at the thorough approach and the clear intent to present material in various ways and with different presenters as to not lose the learner's attention. Great experience.
-
Great course with all information needed for future audits.
-
This is a pretty good course. I took it as a refresher.
-
The course is useful and meets the purpose.
-
Overall very good course and as I had done previous courses this course brought it all together for me.