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Note: Presenters/Panelists listed below subject to change.
R&Q is bringing our Advanced EU MDR and CER Workshop to DeviceTalks West! Join us Dec.12 for an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. These experts have seen what works and what doesn't, and will be sharing tips, tricks, and lessons learned.
What's more, if you'd only like to attend the workshop and not the entire conference, we've made that possible. Here are the registration codes:
RQFULL - 50% full conference pass
RQWORKSHOP - $75 for workshop only (also includes networking opportunities)
At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020.
Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.
When
Dec. 12, 8:30am - Noon
Where
Hilton Orange County/Costa Mesa (part of DeviceTalks Boston)
Agenda (descriptions further down)
8:30 – 9:00am: Networking with coffee, continental breakfast
9:00 – 10:15am: Transitioning from MDD to MDR
10:20 – 11:00am: Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs
11:10am – 12:00pm: Post-Market Surveillance Under EU MDR
Session detail
9:00am - 10:15am - Transitioning from MDD to MDR
Presenters/Panelists:
Caroline Leab, Director, Regulatory Affairs, Abbott
Artha Nafie, Independent Consultant / EU MDR Program Manager
Nancy Morrison, Director of Regulatory Affairs, R&Q
Here’s nearly everything we’ve learned from multiple implementations that impacts regulatory, quality, and clinical professionals. We’ll pull from our experience of successfully executing large- and small-scale EU MDR implementations and illustrate how it happens. From gap assessments of regulatory files and the QMS to the transition of technical documentation and pilot submissions to the notified bodies – it’s all here. This session will also cover portfolio planning as an input to your implementation plan, and how inputs are used to realign and reduce regulatory files, schedule remediation and file transition activities, and propose portfolio plan revisions that are extremely beneficial to the company considering the significant cost and resources needed to transition products to the EU MDR.
Prepare to return to your organizations inspired by real-world examples and ready to act, with recommendations for impacting the development of project plans, schedules, process, templates, portfolio plans, budgets, and more.
10:20am - 11:00am - Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs
Presenters/Panelists:
Jordan Greenberg, Director, Clinical Research, Regulatory (CEP, CER), Abbott
Jon Gimbel, Director and CER Business Unit Lead, R&Q
These are stories you’ll want to hear. MEDDEV 2.7/1 Rev. 4 and the new European Union Medical Device Regulation (EU MDR) have raised a lot of questions in the regulatory and clinical affairs communities. This panel will feature medical device manufacturers and device consultants who have had the opportunity to create CERs for products in a wide range of clinical specialties being submitted to a variety of notified bodies. Our panel has seen it all and will share the most impactful lessons learned from every aspect of the CER process. From a strategy for finding data to establish equivalence to completion of state of the art analysis, the speakers have encountered plenty of obstacles… and found solutions. Speakers will discuss case studies featuring a multitude of challenges. For example, what should you do with a low-risk device that has no clinical data? And what about a device that will be up-classed from IIb to III? How much historical information do you need in your CER if this is its first review under the MDR? How will the new EU MDR impact your clinical evaluations? Attendees will return to their organizations with actionable ideas and recommendations to impact decisions and apply plans on how to address the requirements.
11:10am - 12:00pm - Post-Market Surveillance Under EU MDR
Presenters/Panelists:
Nancy Morrison, Director of Regulatory Affairs, R&Q
Jon Gimbel, Director and CER Business Unit Lead, R&Q
What is ‘sufficient clinical evidence’ and what does it look like as part of PMS? The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address options for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally in this session, we’ll cover requirements for PMS planning and PMS reporting for all classes of devices. With significant new requirements for device-specific plans and reports, you’ll need to update your post-market surveillance system with enough time for your staff to implement the changes. The requirements seem to overlap with the CER requirements. How can you optimize your process to take avoid duplication of efforts? Are you really ready?
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