This course provides the basic knowledge to prepare for the Medical Device Single Audit Program (MDSAP). It helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global quality systems expert, Kim Trautman. Learn about the MDSAP audit model, grading nonconformances and regulatory transition timelines, to name just a few highlights.
By the end of this course, you should:
- Understand the new regulatory audit findings/nonconformance grading system and know what grades trigger regulatory follow-up within MDSAP
- Learn the value of the MDSAP audit model
- Be familiar with the premise of the MDSAP audit time calculations
- Be familiar with the basic information to be included in the MDSAP audit report
- Understand the MDSAP timeline and other upcoming regulatory changes
By completing/passing this course, you will attain the certificate Medical Device Certificate
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