10th Annual European Medical Device Regulatory Affairs Conference

November 13-14, 2019 | Brussels, Belgium

10th Annual European Medical Device Regulatory Affairs Conference
November 13-14, 2019 | Brussels, Belgium

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WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

“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:

Facing the final period ahead of the EU MDR compliance deadline in 2020, the 9th Annual European Medical Device Regulatory Affairs Conference will focus on the next steps for industry executives and new regulatory guidance which is on the horizon, focusing on continuously improving the safety of medical technologies. Topics will consider future evolution of global regulatory policies and European alignment with global movements, the impact of Brexit on regulatory structures in the United Kingdom, as well as continued focus on enhanced clinical evidence requirements.

Core Topics to be Addressed:

  • In-Depth Analysis of Clinical Evidence Requirements
  • Meeting Enhanced Labeling Requirements Globally
  • Risk Mitigation Efforts Aligned with MDR Transition
  • Ensuring Reclassified Medical Products Meet Requirements
  • Regulatory Pathways for Medical Device Product Software

Program Highlights:

  • Strategies for Moving Beyond MDR Compliance
  • Perspectives from Multiple Authorities Including:
    • Notified Bodies
    • Competent Authorities
    • EU Commission
    • Industry Authorities

Core Topics to be Addressed:

  • In-Depth Analysis of Clinical Evidence Requirements
  • Meeting Enhanced Labeling Requirements Globally
  • Risk Mitigation Efforts Aligned with MDR Transition
  • Ensuring Reclassified Medical Products Meet Requirements
  • Regulatory Pathways for Medical Device Product Software

Download Agenda

WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

Audience

75 Attendees

All attendees come directly from medical device companies

Distinguished Presenters

25 Speakers

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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