Complaints and Medical Device Reporting

Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical they are frequently inspected areas by the FDA. More importantly, complaints can be also be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting. Complaint management and MDRs are critical quality systems to your 3 key stakeholders - the customer, the regulators, and your business.

Complaint Handling and Medical Device Reporting are essential processes to ensure the safety and efficacy of your medical devices. As such, they are also frequently inspected by the FDA. It is critical that you understand and create efficient and effective processes.

• The purpose of the New Rule
• Overview and Definitions
• FDA Expectations, Regulations
• Lessons Learned and Enforcement Case Studies
• Processes and Procedures
• Reportability Criteria
• Investigating a complaint or MDR
• Linkages between Complaint Handling, MDRs, and CAPA
• Common Mistakes and how to avoid them
• Best Practices
• Preparing for an FDA or NB Inspection

• Understand regulations and expectations
• Review enforcement case studies for lessons learned
• Determine needed processes and procedures
• Identify best practices
• Understand the linkage between complaints, investigations, MDR reports, and CAPA
• Preparing a plan for inspection readiness

This webcast will be of a valuable assistance to the below audience.

• Complaint Specialists and Managers
• Complaint Handling Unit
• Individuals participating in Failure Investigations
• Individuals analyzing returned products / Complaint Analysis
• Regulatory Affairs
• Quality Engineers
• Clinical Affairs
• Compliance Specialists
• Auditors
• Senior Management
• Field Sales