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 complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard.
Note: Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.
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)
By completing/passing this course, you will attain the certificate Medical Device Certificate
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