Post-Market Surveillance Activities (FDA and EU-MDR) – A Detailed Analysis

Post Market Activities are a GMP regulatory requirement for the medical device industry in both the US and European Union. These activities provide a valuable system for obtaining data and continuous feedback about a medical device that is on the market. The objective of Post Market Activities is to utilize real-world data in order to maintain a high standard of product quality and ensure patient safety.

Recently, the European Union has revised the regulatory requirements governing medical devices; including the establishment of new expectations and approaches to post-market surveillance. Mandatory compliance to the new European Medical Device Regulation (MDR) is set for 26 May 2020. Due to the regulation changes, medical device manufactures are focused on implementing quality systems to maintain GMP compliance. In order to achieve that goal, it is essential that medical device manufacturers understand and correctly implement the requirements for post-market surveillance.

This webinar will discuss the essentials of Post Market Surveillance, how you can develop your capabilities and how PMS can provide you with important information to improve your device, better service your customers, and reduce the risk of adverse events. This course will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches to ensuring compliance.

Why You Should Attend:

  • What are the key elements of a PMS system?
  • How should a PMS system function?
  • What is the role of risk management in PMS?
  • How do I implement data collection and review procedures
  • How does a PMS system benefit my company?

Areas Covered in the Session :

Post-Market Surveillance

  • FDA Expectations, Regulations
  • Investigating a complaint or MDR
  • FAERS – FDA Adverse Event Reporting System
  • Common Mistakes and how to avoid them
  • Best Practices

Review the new EU-MDR

  • Key compliance dates
  • Transition from Re-active to Pro-active
  • Data Inputs and Collection Methods
  • Trending

Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Departments
  • Compliance Departments
  • Engineering Departments
  • Clinical Affairs Professionals
  • Complaint Specialists and Managers
  • Individuals participating in Failure Investigations
  • Individuals analyzing Returned Products/Complaint Analysis
  • Complaint Handling Unit Personnel

MD3202SM

Susanne Manz

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance