EU-MDR: Are You Ready?: Part III – Webinar Recording/Transcript
EU-MDR: Are You Ready? — Part III: Ensuring Your Postmarket Surveillance Readiness
After a successful notified body audit, certificates are issued a CE Mark is applied and the device enters the postmarket surveillance phase. But how well do you understand the PMS phase’s precursors? After all, the notified body document review includes the PMS plan and the plans inside it: the complaint management plan, the trend report plan, and, if applicable, the postmarketing clinical follow-up (PMCF) plan.
Once the PMS phase begins, you must execute your PMS plan: collect data, analyze it and write the evaluation report. If PMCF applies, you must implement the PMCF plan, prepare the PMCF evaluation report and use them to update risk management and, if required, the clinical evaluation report. If you’re unclear about any part — from the premarket plans to the post-market reports — this training is a must.
Join us to understand the EU-MDR PMS system and how to implement the requirements.
- How to prepare your PMS plan
- How to prepare other related plans — the complaint management plan, the trend report plan and if applicable, the PMCF plan
- How to determine the reports required for the PMS System
- How to determine when to prepare a PMCF plan
- Understand the content of the PMCF Evaluation Report
- How to link PMS data and PMCF data to risk management
Get a handle on the EU-MDR PMS system so you can successfully implement the requirements.
Meet Your Presenter:
Dan O'Leary is 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. He has more than 30 years’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Master’s Degree in Mathematics; is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt.
Who Will Benefit:
- Medical device / technology companies
- Quality manager
- Regulatory manager
- Operations manager
- Design manager
- Technical manager
- Clinical manager
- Authorized representative in Europe