It’s happening: 2020 is here and we are mere months away from the official European Union Medical Device Regulations (MDR) May 26 date of application. The corrigenda didn’t get us out of it and COVID-19 has sidetracked everyone. You should be well into your EU MDR transition and familiarized with the new regulations while preparing for the uncertainty ahead.
Whether the upcoming deadline is a cause for comfort or grief – don’t panic! Compliance is possible and our online workshop will get you access to industry and R&Q experts who can answer your questions on the hurdles your organization is facing. In this workshop you can get your questions answered and stay ahead of the deadlines.
RA/QA leaders from multinational medical device companies – along with preeminent RA/QA experts from R&Q – will share strategic solutions for challenging problems that we have seen so far. You will have the opportunity to ask questions throughout the workshop and will leave with an advanced skillset and developed strategies no matter where you are in the EU MDR transition process.
EU MDR Corrigenda and Implementation Dates
(Presentation) This session will cover how to prioritize what needs to be done by May 2020 in order to be EU MDR compliant. It will serve as a check-in point to determine if you are truly on schedule for meeting the transition requirements and break down what you will need to complete by May, even if you feel that you are behind or not quite prepared.
Managing EU MDR Implementation Challenges
(Panel Discussion) Experts come together to discuss examples of implementation challenges that they have seen with client projects so far. This session will also feature a discussion on early Notified Body feedback and what we can all learn from the results, and how to apply it to your individual challenges while minimizing your risk.
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF): Challenges & Planning
(Presentation) You should have PMS Plans by now, but what about procedures? We will elaborate on critical processes and how to optimize them for long-term success. As well as 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.
Clinical Evidence: How Much Do We Really Need?
(Panel Discussion) This panel will focus on the million-dollar question: how much clinical evidence is enough? Panelists in this session will go into detail about strategies to overcome audit findings and gaps in your evidence.
Featured Speakers & Panelists:
- Caroline Byrd, Director, Commercial RA/QA, Leica Biosystems
- Becky Moore, Senior Regulatory Specialist, Peripheral Interventions Divisions, Boston Scientific
- Emily Metcalfe, MS, RAC, Senior Manager Clinical Evaluation - Abbott
- Karen Rittle Leigh, Ph.D., International Regulatory Manager, 3M Health Care Business Group
- Dona Occhipinti, MPH, CCRP, Principal/Founder at MedSmart LLC
- Jonathan Gimbel, Ph.D., Executive Director and CER Business Unit Lead - R&Q
- Nancy Morrison, RAC, Executive Director, Regulatory & Quality Consulting Services - R&Q
- Ibim Tariah, Ph.D., Vice President, EU MDR & IVDR Consulting Services - R&Q
- Facilitator: Theresa Miles, Director Client Solutions - R&Q