Event Details

There is one month until your postmarket surveillance (PMS) system must comply with the EU MDR. How's it going?

 

We've heard loud and clear an abundance of last-minute issues and questions. 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 using several real-world examples. The presentation will include examples of the following:

• 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 does justification for not conducting PMCF work?

• Pressure testing your systems: how to 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 webcast will go into detail about strategies to overcome audit findings and gaps in your evidence. 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. All webcast attendees will leave with the ability to impact their organizations, no matter where their organizations are in the implementation process.

 

Learning Level

• Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

 

Learning Objectives

• Identify requirements for PMS on the date of applicability (26 May 2020) of the EU MDR.

• How to prepare for notified-body audits related to PMS and avoid common findings.

• Conduct an integrated review of systems to ensure alignment across systems required to support or impacted by PMS.

 

Who Should Attend?

• Regulatory and quality affairs professionals

• Supply chain representatives

• Clinical affairs professionals

 

Speaker

Nancy Morrison, executive director, regulatory and 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.

 

Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.