Course "Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

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

Course Outline:

Day One (8:30 AM - 5:00 PM) Day Two (8:30 AM - 5:00 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

Welcome and Introductions

  1. The Basics of Quality System Regulations
    1. Regulatory Overview
    2. General Provisions of the Regulation
    3. Quality Management
    4. Monitoring and Feedback
    5. Purpose of Risk Management
  2. Understanding Your Compliance Profile
    1. What makes up a company’s compliance profile
    2. What is the impact of a company’s compliance profile
    3. How to improve and enhance your compliance profile
  3. 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
  4. Review & Recap

Welcome and Recap

  1. Medical Device Reporting
    1. Review of the MDR regulation
    2. Sources of MDRs
    3. Submission MDRs (initial and follow up)
    4. Proper completion of the MedWatch form
    5. Effective utilization of MDR data
  2. 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
  3. Medical Device Recalls
    1. Review of the regulation
    2. What is a recall?
    3. Managing a product recall (US and Globally)
    4. Utilizing internal resources
    5. Recall records
    6. Coordinating with regulatory agencies
    7. Closing out a product recall
  4. Product Complaints, MDRs, and Product Recall Remediation Projects
    1. What is the purpose of a remediation activity
    2. Developing a remediation plan
    3. Executing the remediation plan
    4. Recording results of the remediation activity
  5. Review and Recap

Meet Your Instructor

Douglas Fortunato
Regulatory Affair Consultant

Douglas Fortunato, has over 28 years of domestic and international regulatory affairs experience, with expertise in product complaint management, medical device adverse event reporting (MDR and Vigilance reporting), and medical device product recalls. Mr. Fortunato has recent hands on and practical experience in all post market surveillance areas.

He worked for Bausch & Lomb Incorporated for 29 years. He was responsible for the management of Global Product Surveillance, which included product complaints management; medical device reporting (MDR) and adverse event reporting; and medical device product recalls. He individually managed over 30 medical device product recalls while at Bausch & Lomb.

Most recently he worked on a consulting basis for a medical device manufacturer that was under an FDA Consent Decree. He was the internal lead for two Quality System Work Streams (Complaints Management and Medical Device Reporting) while also managing day-to-day activities for those two functions. He enabled both the complaints and MDR functions to reach their steady state goal, reducing both the number of aged open complaints and the overall number of open complaints through process, procedure and staffing enhancements.

Additionally, he was assigned as the External Subject Matter Expert for the Corrections and Removals Work Stream. He optimized the recall process and procedures in order to improve efficiency and sustainability.

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General Driving Directions:

Driving Directions from Boston Logan International Airport – BOS: 3.2 mile(s) NE
  • Follow signs for Boston/Sumner tunnel.
  • Pay the toll and stay in the right lane in the tunnel.
  • Follow signs for Exit 26/Storrow Drive. After you emerge from the tunnel, take the second left exit to Copley Square/Back Bay.
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  • After 5 lights, Exeter St. ends at Huntington Ave. Turn right onto Huntington Ave.
  • At the first light, under the sky bridge, make a U-turn to the left. The hotel entrance will be immediately on your right.

Other Transportation:

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Subway Station
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Train Station
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Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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