3rd Annual EU MDR Implementation Conference

July 2019 | Arlington, VA
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“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs
Orexigen

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison
Biogen

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head
BIOMERIEUX

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead
Genentech

About the Conference:

As the 2020 EU MDR compliance deadline approaches, regulatory affairs executives are racing against the clock to implement all requirements of the specification to ensure compliance for products currently on the market as well as those in development looking to secure certification in the near term. With a speaker roster incorporating perspectives from multiple notified bodies working with device corporations to secure product registrations, industry experts with deep experience in European regulatory requirements and the shift from the MDD to MDR, participants will have an opportunity to make final assessments and preparations ahead of final deadlines.

Topics to Be Addressed:

  • Practical industry examples of final gap assessments
  • Tools for interpreting analysis & implementing requirements
  • Troubleshooting scenarios in late-stage implementation
  • Legacy product decision making: Recertification experiences
  • Industry and Notified Body collaboration and best practices
  • Conformity assessments for multiple product classes

Program Highlights:

  • Direct collaboration and Q&A with Notified Body experts
  • Practical industry perspectives on current implementation
  • Multiple hands-on workshops to engage participants

Audience

75 Attendees

All attendees come directly from medical device companies

Distinguished Presenters

Speaker recruitment in process

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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