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.
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.
Maria Fagan – Cofounder and President
Regulatory & Quality Solutions (R&Q)
Maria co-founded R&Q in 2008 and has been focused on business balanced growth from inception. Maria ensures that the R&Q business is strategically focused on growth and that R&Q’s vision and mission are upheld and R&Q is poised for success. Having worked at R&Q since the beginning, Maria has an expert understanding of the consulting industry as well as the medical device Industry. Maria has nearly 30 years of Industry experience in medical device development across RA/QA areas, as well as post-surveillance and compliance. Maria capitalizes on this experience to ensure that R&Q continues to provide top quality strategic and tactical solutions to the Industry.
Prior to co-founding R&Q, Maria held positions at MEDRAD a Malcolm Baldridge winning company and one of Pittsburgh’s top medical device companies. Maria’s previous positions included Director of Quality Assurance and Regulatory Affairs for Europe, as well as Manager of Quality Assurance for New Products where she led a team of professionals that provided a broad range of quality and regulatory services to product development teams. Maria holds an Executive Leadership Program certificate from Carnegie Mellon University’s Tepper School of Business and a B.S. in Mechanical Engineering from the University of