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R&Q Webinar: PMS Requirements of the EU MDR
February 25 @ 1:00 pm - 2:00 pm
There are three months until your post-market surveillance (PMS) system complying to the EU MDR must be put into place. How’s it going?
We’ve heard loud and clear an abundance of last-minute issues and questions.
This webinar is the premier opportunity to learn from the experiences of seasoned experts as they share their PMS/PMCF successes and failures so far.
While there have been and will continue to be plenty of implementation challenges, our Executive Director of Regulatory and Quality Consulting Services has worked through comprehensive solutions and is prepared to share them. From more significant challenges than expected to understanding what the notified bodies really want to see; examples of topics include:
– Getting fully prepared for your notified body audit.
– You should have PMS Plans by now but what about Procedures? We’ll elaborate on critical processes and how to optimize them for long-term success.
– The risks of doing a justification for PMCF and did your justification for not conducting PMCF work?
– Pressure testing your systems: how do you gather all the data sets and integrate them into cohesive PSURs and PMS Reports even when the data sets are from disparate systems.
– Integrating your PMS program with CERs, risk management, technical documentation, and labeling to optimize efficiency.
This webinar will go into detail about strategies to overcome audit findings and gaps in your evidence. All webinars attendees will leave with the ability to impact their organizations, no matter where their organizations are in the implementation process.
If you want to help optimize every element of PMS/PMCF as it relates to the EU MDR at your organization, this is the definitive session for you.