Managing Medical Device Complaints - Webinar CD/Transcript
Managing Medical Device Complaints
Complaint management is one of the most frequently cited QSR violations in warning letters.
An effective complaint management system must be compliant with several requirements including:
- Medical Device Reports
- Unique Device Identifier
Manufacturers need to establish top-rung complaint procedures as well as creating records and documents that ensure smoothly functioning QMS along with FDA compliance.
Join industry expert Dan O’Leary for an in-depth review and analysis of FDA inspection techniques, QSIT and warning letters.
He will provide practical, real-world tips on the:
- QSR definition of a complaint
- Requirements to investigate a complaint
- Qualification requirements for people who investigate complaints
- Data elements for every complaint investigation
- Effect of UDI on these required records
- Connection between complaints and medical device reports
- Connection between complaints and risk management
- Differences in ISO 13485:2003 and ISO 13485:2016
- Trend analysis requirements in the EU Vigilance system and when to report complaints
Order today for a concrete understanding of how complaint files are managed across both domestic and international facilities.