15th Annual Medical Device Quality Congress

precon

Post-market Surveillance

8:00 a.m. – 8:30 a.m.

Continental Breakfast and Registration

8:30 a.m. – 5:30 p.m.

Medical device manufacturers can’t just design, manufacture, and ship product – they must learn how the device performs and identify any patient or user issues too once it is out in the real world. This process has many names, but it is most commonly called post-market surveillance or PMS.

To meet these obligations, device manufacturers must have a system to collect data, process information, create knowledge, update the quality management system, update the risk management system, and report to regulators. Although many systems have a common framework, the details on what is required vary widely by regulatory region. This workshop employs the framework and provides the details for the US, the EU under the directives, and the EU under the regulations. PLUS, we provide tools to help you manage your program!

A starting point is risk management. The PMS information helps detect any weakness in the risk control measure’s ability to keep a harm’s severity and frequency at an acceptable level.

For the US, the workshop describes the requirements and methods for complaint management, how to use FDA’s Total Product Life Cycle (TPLC) database, Part 803 Medical Device Reports, Part 806 Corrections & Removals, Part 821 Medical Device Tracking, and Part 822 Post Market Surveillance.

For the EU-MDD, the workshop describes Clinical Evaluation, Post-market Clinical Follow-up (PMCF), Vigilance Reporting, Field Safety Corrective Actions, and Trend Reporting.

The EU-MDR expands the PMS system and adds additional reports to regulators (including Notified Bodies). The workshop describes Benefit-Risk Determination (BRD), Benefit-Risk Ratio (BRR), Clinical Evaluation (CE), Post-market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Post-market Clinical Follow-up (PMCF), and the Summary of Safety and Clinical Performance (SSCP). Many of these provide information to others, creating an interesting web.

Attendees will learn:

  • The risk management process to update the risk management file using the PMS system
  • Statistical methods for signal detection
  • Using complaints to learn about your device
  • Using the TPLC database to learn about other manufacturer’s devices
  • The systems to report adverse events to regulators
  • The systems to revise devices already shipped
  • The linkages between clinical evaluation, risk management, and post-market clinical follow-up
  • The new set of plans and reports in the EU-MDR and how to implement them
  • How to implement the EU-MDR’s trend analysis for non-serious incidents

BONUS: Attendees will receive implementation tools including checklists for procedures, plans, and reports.

Expert Instructor:

Dan O’Leary, President, Ombu Enterprises LLC

5:30 p.m.

Training Adjournment

 

register

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