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Medical Alley Association and R&Q Present: Strategic Solutions for EU MDR W...

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Doubletree by Hilton Minneapolis – Park Place

1500 Park Place Blvd.

Minneapolis, MN 55416

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Medical Alley Association and Regulatory & Quality Solutions (R&Q) are partnering to bring you a free half-day industry leading Strategic Solutions for EU MDR Workshop in the Minneapolis area.

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 no additional delays are coming, so by this time you should be well into your EU MDR transition and familiarized with the new regulations.

Whether the upcoming deadline is a cause for comfort or grief – don’t panic! Compliance is possible and our half-day workshop will get you in a room with experts and peers that are facing similar hurdles so that 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 day and will leave with an advanced skillset and developed strategies no matter where you are in the EU MDR transition process.

Please see the agenda breakout for specific detail on each session and we hope to see you at the event!

The goal of this event is to educate medical device manufacturers and based on limited seating, we are prioritizing registrations first for medical device manufacturers. If seats remain available closer to the event date, we will open up registration to service providers and consultants. Please note the different ticket types.



Agenda

8:00 a.m. – 8:30 a.m.
Registration & Networking

8:30 a.m. – 9:00 a.m.
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.

9:00 a.m. – 10:00 a.m.
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.

10:00 a.m. – 10:45 a.m.
Brunch & Networking

10:45 a.m. – 11:15 a.m.
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.

11:15 a.m. - 12:30 p.m.
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
  • Karen Rittle Leigh, Ph.D., International Regulatory Manager, 3M Health Care Business Group
  • 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

FAQs

What are my parking options for getting to and from the event?

Parking is FREE at the the Doubletree Minneapolis - Park Place.

How can I contact the organizer with any questions?

Please contact Deven Snyder, Regulatory & Quality Solutions (R&Q) at DSnyder@RQTeam.com

What are recommendations if I am coming to the event from out of town?

Click here for directions to the hotel & transportation recommendations.

Airport: The venue is about 16 miles northwest of the Minneapolis-St. Paul International Airport (MSP).

Hotels: The venue is a hotel and there are several other options in the surrounding area. Here are a few that are rated above four stars on Google:

DoubleTree by Hilton Hotel Minneapolis - Park Place (EVENT VENUE)

TownePlace Suites by Marriott Minneapolis West/St. Louis Park

Homewood Suites by Hilton Minneapolis- St. Louis Park at West End

SpringHill Suites by Marriott Minneapolis West/St. Louis Park

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Date and Time

Location

Doubletree by Hilton Minneapolis – Park Place

1500 Park Place Blvd.

Minneapolis, MN 55416

View Map

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