Complaint Handling & Medical Device Reporting (MDR) 2016

Key Topics

• Definitions
• Applicable Laws and Regulations
• Requirements for Medical Device Reporting
• Requirements for Complaint Handling
• Key Elements in the Procedures: Complaint Handling and MDR
• Applicable Processes and Procedures
• What/How/When to Investigate a Complaint
• What to Do When a Complaint Is Received
• Medical Device Reporting
• Complaints Investigation and Documentation
• Establishing Reportability Criteria
• How to Determine Reportable Events
• Mistakes and How to Avoid Mistakes and 483s
• Additional Documentation Requirements for MDR
• Enforcement Case Studies
• Relationships between Complaint Handling, MDR, and CAPA
• Speaker’s PASS-IT suggestions and recommendations
• Improving Our Awareness and Continuous Improvement

Who should Attend

• Regulatory Affairs
• Complaint Managers
• Clinical Affairs
• Quality
• Compliance and Legal Affairs
• R&D engineers and scientists, managers, directors, VPs
• Auditors and Consultants
• CRO
• Anyone Interested in Medical Device Complaint Handling Systems
• Senior Management