Note: this webcast is now available on demand.
R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and on Wednesday, April 15th, we're joining forces to offer up a premium live webcast.
Attendees will earn 1.5 RAC credits and the event is free.
R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, will be presenting PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar will be an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. An hour and a half has been allotted and Nancy will be taking live questions. This is your chance to get difference-making information from one of the industry's utmost thought leaders and apply it to your own organization.
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.
About the presenter
Nancy Morrison – Executive Director, Regulatory & Quality Consulting Services
Regulatory & Quality Solutions (R&Q)
Nancy has over 30 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous seven years have been with R&Q working with start-up, mid-size and multi-national medical device and combination product companies. Nancy has a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU. Nancy has been providing EU MDR and IVDR leadership in developing solutions and implementing the regulations at small and large organizations.