Topics
- Firms MDR reporting and FDA`s handling of reports
- How to comply with complicated Compliant Handling, MDR and Recall requirements
- Minimizing risk of regulatory enforcement actions
- Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
- The relationship and interaction with other quality system elements as they relate to complaints and reportable events
- Creation and maintenance of effective procedures for handling complaints, reportable events and recalls
- Walk-through of case examples
Who should Attend
Attendees from medical device industry involved in recalls, product complaints and medical device reporting, including QA/QC, Regulatory Affairs, Regulatory Professional, Project Managers, Complaint Handling Teams, Risk Managers and CAPA Teams.
