Online course on post-market surveillance of medical devices:

ByMike V. Cooper

Jul 1, 2022

Dublin, July 01, 2022 (GLOBE NEWSWIRE) — The “Medical Devices – Post-market Surveillance: Product Complaint Management, Medical Device Reports, Vigilance Reports, Product Recalls” training has been added to from offer.

This course will provide practical advice and concrete examples that will help you develop and/or optimize your company’s post-market surveillance system. It is essential to have an effective, efficient and robust post-market surveillance system for medical devices.

These are key elements for early identification and rapid response to problems with marketed products. Besides the obvious need to comply with regulatory requirements, it is also vital from a business perspective to understand the importance of managing complaints, MDRs, vigilance reports and product recalls. A robust post-marketing surveillance system helps prevent unnecessary patient injury, reduces the risk of financial loss, and could lead to product improvements.

Complaint management, MDRs, EU Vigilance Reports and Product Recalls are top priorities for FDA and Notified Body inspections. For example, 40% of all FDA warning letters are related to complaints management system issues. In addition, four recent warning letters issued by the FDA concerned issues with MDRs.

This interactive seminar will focus on:

  • Claims management
  • Medical Device Report (MDR)
  • EU vigilance reports
  • Product recalls

Learning objectives:

The main objective of this course is to understand:

  • Legal authorities (laws and regulations) and definitions applicable to the key elements of post-market surveillance (complaint management, MDR, vigilance and product recalls)
  • Regulatory and compliance requirements related to each element of post-market surveillance (complaint management, MDR, vigilance and product recalls)
  • Implement applicable processes and procedures for complaint management, MDRs, vigilance and product recalls
  • Management review and dissemination of post-marketing surveillance information
  • What to do when a complaint is received:
    • What/how/when to investigate a complaint
    • Content of Complaint Investigation Records
    • How to decide the complaint
    • Implement interactive systems between complaint handling, medical device reporting and CAPA
  • Submission of MDRs to the FDA:
    • What/how/when to submit an MDR
    • Content of the declaration form
    • Use of MDR information as qualitative data
  • Submission of Vigilance Reports to Competent EU Authorities:
    • What/how/when to submit a vigilance report
    • Content of the declaration form
  • What to do when a medical device needs to be recalled:
    • What/how/when to initiate a medical device product recall
    • Content of Recall Reports and Records
    • Execution and closure of the recall
  • To discuss key case studies and how to prevent compliance issues related to complaint handling, MDR, vigilance reporting and medical device product recalls
  • Review the key concepts and steps for implementing an effective post-market surveillance system

Time: 9:00 a.m. – 4:30 p.m. PDT

Who should attend:

Anyone involved in product complaint management, medical device reporting, vigilance reporting and/or product recalls:

  • Regulatory Affairs Staff
  • Quality managers and people working in sales or marketing
  • Legal staff
  • Compliance professionals
  • Clinical Affairs Specialists and Complaints Handlers
  • Medical Affairs Professionals
  • Design control managers
  • Risk managers

July 29, 2022 (9:00 a.m. to 4:30 p.m. PDT)

Registration process: 8:30 a.m. – 9:00 a.m.

9.00 – 10.30: The basics of quality system regulation and post-market surveillance activities

  • Regulatory overview
  • General provisions of the regulations
  • Quality management
  • Monitoring and feedback
  • Objective of risk management

10:30 a.m. – 11:30 a.m.: Management of product complaints

  • What is a complaint?
  • Why do we collect product complaints
  • Management of product complaints
  • Development of a complaints management procedure
  • Analyze product complaint data
  • Effective use of product complaints data

11:30 a.m. – 12:30 p.m.: Declaration of medical devices

  • Revision of the MDR regulation
  • Sources of MDRs
  • Submission MDR (initial and follow-up)
  • Efficient use of MDR data

12:30 p.m. – 1:30 a.m.: Lunch

1:30 a.m. – 2:45 a.m.: European medical device vigilance report

  • Review of reporting requirements
  • Submission of Vigilance declaration forms
  • Complete the Vigilance report form correctly
  • Dealing with notified body and competent authorities

02:45 – 04:00: Recalls of medical devices

  • Settlement Review
  • What is a recall?
  • Other types of actions
  • Use of internal resources
  • Recalling recordings
  • Coordination with regulatory agencies
  • Closing a product recall

04.00 – 04.30: Questions and answers


Teacher. Dr hc Frank Stein
Senior Medical Device Expert
Nemius Consulting GmbH

Dr. hc Frank Stein, medical engineer, 25 years of medical engineering experience, 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 experience in regulatory advice in Europe, North America, Asia, Australia, Arab Countries, Latin America.

For more information on this training, visit