One-Day Virtual Seminar

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

BY: Prof. Dr. h.c. Frank Stein, Senior Medical Device Expert, Nemius Consulting GmbH

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Simu Live
(On-demand Streaming - Virtual Training Through WebEx)
  • Course Description
  • Agenda
  • Speaker
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It is essential to have an effective, efficient and robust medical device post market surveillance system.

This two day interactive seminar will focus on:

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

These are key elements for early identification and rapid response to problems with marketed products. In addition to the obvious need to comply with regulatory requirements, it is also vital from a business standpoint to understand the importance of complaint management, MDR’s, vigilance reporting and product recalls. A robust post market surveillance system helps to prevent unnecessary patient injuries, reduces the chances for financial loss, and it could result in improved products.

Complaint management, MDRs, EU vigilance reporting, and product recalls are top priorities in FDA and notified body inspections. For example, 40% of all FDA Warning Letters are related to issues involving the complaint management system. Additionally, four recent Warning Letters issued by the FDA involved issues related to MDRs.

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
Day 01(9:00 AM - 4:30 PM PST)
  • Registration Process: 8:30 AM - 9:00 AM
  • 9.00 - 10.30 : The Basics of Quality System Regulations and Post Market Surveillance Activities
    1. Regulatory Overview
    2. General Provisions of the Regulation
    3. Quality Management
    4. Monitoring and Feedback
    5. Purpose of Risk Management
  • 10.30 - 11.30 : Product Complaint Management
    1. What is a complaint?
    2. Why do we collect product complaints
    3. Management of product complaints
    4. Developing a complaint management procedure
    5. Analyzing product complaint data
    6. Effective utilization of product complaint data
  • 11.30 - 12.30 : Medical Device Reporting
    1. Review of the MDR regulation
    2. Sources of MDRs
    3. Submission MDRs (initial and follow up)
    4. Effective utilization of MDR data
  • 12.30 - 01.30 : Lunch
  • 01.30 - 02.45 : Medical Devices European Vigilance Reporting
    1. Review of the reporting requirements
    2. Submission of Vigilance reporting forms
    3. Proper completion of the Vigilance reporting form
    4. Dealing with Notified Body and Competent Authorities
  • 02.45 - 04.00 : Medical Device Recalls
    1. Review of the regulation
    2. What is a recall?
    3. Other action types
    4. Utilizing internal resources
    5. Recall records
    6. Coordinating with regulatory agencies
    7. Closing out a product recall
  • 04.00 - 04.30 : Questions and Answers
Frank Stein
Frank Stein Senior Medical Device Expert, Nemius Consulting GmbH

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

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