PMS Requirements of the EU MDR

"RAPS and R&Q came together to create an exceptional presentation on PMS requirements with experiences gained during audits from Notified Bodies. This was incredibly timely and helpful. Thank you!"

"Clearly spoken and enthusiastic, very easy to listen to with a good amount of anecdotes and humor to help in the delivery."

"This was honestly fantastic. I am very glad I attended this. The speaker was phenomenal."

"Presenter went at a great pace, was very well organized and very easy to understand and follow. She focused on practical issues and provided her real-life experience, which is very useful. No technical difficulties so webcast went smoothly. Significant Q&A time was a great addition to the prepared slides."

"Excellent presenter. Great to hear about some real world experiences in addressing this complex topic."

"A very well spent 90 minutes. The presenter was excellent and knowledgeable on the topic with great facilitation and time for questions at the end."

"Excellent MDR / PMS "current state" overview. The presenter was clearly an expert with a deep understanding of the topic. This Webinar was useful for us so that we could gauge our internal MDR program development progress against what the presenter described as "current industry best practices". We have several good takeaways that will assist our organization with MDR Quality System Certification Audit Prep."

"The presenter was extremely knowledgeable not only on the topic of the webinar, but overall MDR requirements. Her slides will be a valuable tool to share with others in my organization. Sharing real world experiences of interactions with various notified bodies was very helpful."

"Outstanding Incredible presentation that was very fluid , hit on all key touch points."

R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and on April 15th, 2020 we joined forces to offer up a premium live webcast.

Attendees earned 1.5 RAC credits for attending.

R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, presented PMS Requirements of the EU MDR: Implementation Challenges and Solutions. This webinar was an extended, enhanced, and more up-to-date version of R&Q's own February 2020 webinar. An hour and a half was allotted and Nancy took live questions for around 30 minutes.

This on-demand webinar 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.

Presenters

Nancy Morrison – Executive Director, Regulatory & Quality Consulting Services
Regulatory & Quality Solutions (R&Q)

Nancy has over 25 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous five 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 the ability to build collaborative relationships with stakeholders to utilize regulations to identify opportunities that provide compliant and effective business solutions.