4th Annual US EU MDR Implementation Conference

July, 2020 | Arlington, VA

4th Annual US EU MDR Implementation Conference
July, 2020 | Arlington, VA

Request Invite

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

“I enjoyed the conference and heard many comments that it was one of the best conferences they have attended. You did a great job organizing the event, speakers, and venue.”

Corporate Vice President Global Regulatory Affairs
Integra LifeSciences

“Thank you very much for the great event! It was really useful for our MDR implementation work.”

Global Manager Regulatory Intelligence
Medela

“Thanks again for the nice organization and hospitality, when organizing the conference this week.”

Principal Certification Manager
DEKRA Certification

“It’s been a pleasure to actively participate. Great opportunity to gain new information and share first experiences with other participants. Thanks, Q1, for organizing the event.”

Regulatory Affairs Manager EMEA
Hu-Friedy

“This was my first Q1 event and I’d like to say it is very professional & organized compared to similar events. Overall very good & comprehensive! Very informative.”

Senior Staff Technical Writer
Stryker Instruments

About the Conference:

With the EU MDR implementation deadline in May of 2020 rapidly approaching, regulatory affairs executives are currently focused on organizing and managing the final steps of the transition to align corporate strategies with new requirements and processes. The 4th Annual US EU MDR Implementation Conference will focus on the time remaining in the transition period and what companies can expect from notified bodies and regulators as the implementation deadline draws to a close, as well as clarifying areas of uncertainty such as implementing acts and defining sufficient clinical evidence.

Core Topics to be Addressed:

  • Risk based approach during final implementation transition period
  • Threshold of sufficient clinical evidence without equivalency data
  • Establishing a relationship and open communication with notified bodies
  • Product prioritization based on certification requirements & market viability
  • Integrating EUDAMED into workflows without implementation guidance

Program Highlights:

  • Real-life case studies from experts who have launched in-house transition
  • Multiple perspectives including notified body and competent authorities
  • Content driven programming focused on collaboration & knowledge share

Core Topics to be Addressed:

  • Risk based approach during final implementation transition period
  • Threshold of sufficient clinical evidence without equivalency data
  • Establishing a relationship and open communication with notified bodies
  • Product prioritization based on certification requirements & market viability
  • Integrating EUDAMED into workflows without implementation guidance

Request Invite

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

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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