Medical Device Post Market Clinical Follow-up Conference

January 22-23, 2020 | Alexandria, VA

Medical Device Post Market Clinical Follow-up Conference
January 22-23, 2020 | Alexandria, VA

Download Overview

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:

The Q1 Medical Device Post Market Clinical Follow Up Conference will provide a platform for discussion and knowledge share, featuring deep dive case studies into the success stories of leading manufacturers who have embraced post market research and who are leveraging the data gathered to provide considerable return on investment. Of particular focus will be interpretations of the EU MDR Article 14, focused on post market requirements for all medical products sold within the European market, with varied perspectives on the definition of sufficient evidence. Further sessions will focus on securing budget and resources, selecting the most appropriate type of research to conduct, as well as a focus on proactive management of complaints in the research setting.

Core Topics to be Addressed:

  • Aligning post market clinical follow up plans with EU MDR clinical evaluation reports & regulatory requirements
  • Use of risk-based modeling to determine sufficient clinical evidence thresholds under the EU MDR framework
  • Management of post market research for legacy and CE marked products within the European marketplace
  • Development of post market clinical follow up plans as part of initial product planning & CE mark dossiers
  • Strategies for highlighting the benefit of post market product data to garner resource and financial support
  • Selection of the most appropriate clinical follow-up method to satisfy regulator & executive leadership demands
  • Focused case study presentations highlighting successful post market research using varied styles of research
    • Gold standard randomized controlled trials
    • Prospective observational studies & registries
    • Systematic literature reviews & meta-analysis
    • Investigator initiated research (IIT/IIS)
    • Use of surveys, apps & customer feedback
  • And More…

Core Topics to be Addressed:

  • Aligning post market clinical follow up plans with EU MDR clinical evaluation reports & regulatory requirements
  • Use of risk-based modeling to determine sufficient clinical evidence thresholds under the EU MDR framework
  • Management of post market research for legacy and CE marked products within the European marketplace
  • Development of post market clinical follow up plans as part of initial product planning & CE mark dossiers
  • Strategies for highlighting the benefit of post market product data to garner resource and financial support
    • And More…

Download Overview

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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