Post Market Surveillance for Medical Devices

Why Should You Attend:

Post market surveillance is changing, not only in the US, but also in the EU and Canada. New rules and regulations are emerging in the countries where the devices manufacturers market their products. The sheer volume of rules and regulations can be daunting, but the differences in each geographic market can be scary.

This webinar explains the aspects of post market surveillance that will help you understand and implement them. The webinar explains the use of post-market surveillance in maintaining your risk management file (ISO 14971) and updating your clinical evaluation (MDD Annex X). In addition, the webinar compares and contrast the rules for adverse event reporting in the US, EU, and Canada.

Areas Covered in the Webinar:

• The Structure of Post Market Surveillance
• US System
  • Complaints (QSR)
  • Medical Device Reports
  • Corrections and Removals
• International Systems
  • Complaints (ISO 13485)
  • EU Vigilance
  • EU FSCA and FSN
  • Canada Adverse Event Reporting
• Post Production Information Collection
  • Risk Management (ISO 14971)
  • Clinical Evaluation (MDD Annex X)

Who Will Benefit:

This webinar provides information that is valuable for people involved in monitoring product performance, maintaining risk management files, updating clinical evaluation, and reporting to regulatory agencies. This typically includes:

• Quality Managers
• Regulatory Affairs Managers
• Risk Managers
• Design Control Managers

Daniel O Leary
President, Ombu Enterprises, LLC

Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Topic Background:

Post-market surveillance is a requirement for medical device manufacturers. PMS can be complicated, but by breaking it down into its parts, it can be accessible. With the understanding of the parts, you can develop and implement a comprehensive system that will help you stay in compliance.

The first phase involves learning information about your product in the market. This information can from customer feedback, complaints, etc. In addition, you can learn about similar products from literature searches and adverse event databases. This information is the basis to update the ISO 14971 Risk Management File as well as MDD Annex X Clinical Evaluation.

The second phase concerns adverse events that you must report to regulators. The reporting requirements and report timing differ in the geographic markets. An event may have a reporting cycle of 10 days in the EU and 30 days in the US.

The third phase concerns modification or removal of a product from the market.

The webinar covers all three phases, provides a high-level overview of the requirements and directs you to the specific documents for the detailed information you need for an effective post-market surveillance system.

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