Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

Key Topics

• Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
• Firms MDR reporting and FDA`s handling of reports
• Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
• Minimize your risk of regulatory enforcement actions
• Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
• Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
• Walk-through of case examples
• Step-By-Step guide to designing Standard Operating Systems for communicating process for firm’s success
• Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

Who should Attend

Attendees from medical device industry that handles functions involving product complaints, recalls, medical device reporting.

• Regulatory Affairs
• QA/QC
• Project Managers
• Regulatory Professional
• Risk Managers
• Complaint Handling Teams
• CAPA Teams