Medical Device QMS: FDA QMSR and ISO 13485 Certificate Program
About 14 hours
Written for quality engineers, QA specialists, and operations staff at medical device manufacturers and suppliers.
Not yet open for enrollment.
Who it is for
Quality engineers, QA specialists, and operations staff at medical device manufacturers and suppliers.
What you will learn
- Explain the key differences between the QSR and the QMSR
- Map an existing QMS to ISO 13485:2016 clauses
- Link design controls with ISO 14971 risk management
- Run complaint handling and CAPA processes that satisfy FDA
- Plan and conduct an internal QMS audit
How it works
Online and self-paced
The lessons are online, so you can study at your own pace.
Opens later
This program is in preparation and not yet open for enrollment.
Hear when it opens
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