Complaint Handling and MDR Reporting
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Who Should Attend
This practical program will be of benefit to all medical
device personnel involved with their company’s Complaint
Systems including:-
Implementation
- Management
- Regulatory Compliance
- Training
- Product Performance Monitoring
- Auditing
Description
Complaint handling systems have come under intense
scrutiny by the FDA in recent years. This course will
examine the current industry FDA environment and will give
you tools for survival. It will provide a step-by-step guide
to the setting-up, operation, management and auditing of
a complaint system for today’s medical device industry
environment.
There will be case studies in which various examples of
complaint systems will be presented. Pragmatic, simple,
statistical trend methods will be reviewed and attendees
will utilize what they learn in a series of workshops.