EU MDR: Quality System Alignment Conference

December 4-5, 2019 | Chicago, IL

EU MDR: Quality System Alignment Conference
December 4-5, 2019 | Chicago, IL

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:

Medical device companies around the world are in the throes of preparing for the upcoming European MDR regulation, which is set to commence on May 26, 2020, and requires a raft of changes and updates to procedures in order for devices to remain part of the European market. The EU MDR: Quality System Alignment Conference will provide quality assurance executives in the USA with the knowledge required to ensure quality systems are in-line with EU MDR regulations, and that the QMS is prepared to align with not only US FDA and international ISO 13485 standards, but also the EU MDR, which takes a comprehensive, lifecycle approach to quality.

 

Program Highlights:

  • Practical understanding how the EU MDR will affect QMS
  • Considerations for updating QMS to MDR / ISO 13485
  • EU MDR supplier quality requirements & best practices
  • Interactive, industry-driven, collaborative approaches to QMS
  • Multiple stakeholder perspectives including Notified Bodies & auditors

Program Highlights:

  • Practical understanding how the EU MDR will affect QMS
  • Considerations for updating QMS to MDR / ISO 13485
  • EU MDR supplier quality requirements & best practices
  • Interactive, industry-driven, collaborative approaches to QMS
  • Multiple stakeholder perspectives including Notified Bodies & auditors

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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