Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls

This two day interactive seminar will focus on:

• Complaint Management
• Medical Device Reporting (MDR)
• EU Vigilance Reporting
• Product Recalls

This course will provide practical guidance and real life examples that will help you develop and/or optimize your company’s post market surveillance system.

Learning Objectives :

Key goal of this course is to understand:

• Legal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
• Regulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
• Implementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recalls
• Management review and dissemination of Post Market Surveillance information
• What to do when a complaint is received:
• What/how/when to investigate a complaint
• Contents of records of complaint investigation
• How to adjudicate the complaint
• Implementing interactive systems between complaint handling, medical device reporting, and CAPA
• Submission of MDR’s to the FDA:
• What/how/when to submit an MDR
• Contents of the reporting form
• Utilizing MDR information as qualitative data
• Submission of Vigilance Reports to EU Competent Authorities:
• What/how/when to submit a Vigilance Report
• Contents of the reporting form
• What to do when a medical device needs to be recalled:
• What/how/when to initiate a medical device product recall
• Contents of the recall reports and records
• Recall execution and closure
• To discussion of key case studies and how to prevent compliance issues related to Complaint Management, MDR, Vigilance reporting and medical device product recalls
• To review the key concepts and implementation steps for an effective Post Market Surveillance system

Who will Benefit:

Anyone that participates in product complaint management, medical device reporting, vgilance reporting, and/or product recalls:

• Regulatory Affairs Personnel
• Quality managers and those working in sales or marketing
• Legal Personnel
• Compliance Professionals
• Clinical affairs specialists and those handling complaints
• Medical Affair Professionals
• Design Control Managers
• Risk Managers