U.S. FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 RequirementsNSF International
U.S. FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 Requirements
Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and CAPA. It provides a side-by-side comparison of the U.S. complaint handling requirements to the ISO 13485:2016 standard.
By the end of this module you will be able to:
- Differentiate between FDA and ISO 13485:2016 requirements
- Identify the structure of a functioning complaint handling system
- Recognize when events related to servicing activities represent complaints
- Describe the relationship between complaint handling, service reports, and Corrective and Preventive Action (CAPA)
For more information Visit University Website.
Certification / Credits
By completing/passing this course, you will attain the certificate Medical Device Certificate
About NSF International
NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...
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