Complaint Handling and Medical Device Reporting: Need to Know Essentials

Complaint Management and Medical Device Reporting (MDR) are critical quality systems for a medical device company to meet the needs of its 3 key stakeholders – the customer, the regulators, and your business. This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll learn about FDA expectations and regulations as well as lessons learned from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. In addition, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices so you can be prepared for an FDA inspection.

• Overview and Definitions
• FDA Expectations, Regulations
• Lessons Learned and Enforcement Case Studies
• Processes and Procedures
• Flow Chart
• 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

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 by the FDA. More importantly, complaints can 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 Specialists and Managers
• Individuals participating in Failure Investigations
• Individuals analyzing returned products / Complaint Analysis
• Regulatory Affairs
• Quality Engineers
• Clinical Affairs
• Complaint Handling Unit Personnel
• Compliance Specialists

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.