Medical Device Complaint Handling and Servicing

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 corrective and preventive actions (CAPA). It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in 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 medical device complaint handling system
• Recognize when events related to servicing activities represent complaints
• Describe the relationship between complaint handling, service reports and CAPA

This 1.5-hour course is vital for any medical device quality professional, including quality directors, managers, engineers and auditors responsible for implementing a quality management system in accordance with ISO 13485:2016.

By completing/passing this NSF medical device complaint handling training, you will attain the Medical Device Certificate.