events

Meet and Greet Qserve Experts at RAPS Convergence 2026

Written by Amé Huige | May 27, 2026, 10:13:51 AM

Date: 14 - 17 September 2026

Location: Charlotte Convention Centre, Charlotte, North Carolina, USA

Language: English

Introduction

RAPS Convergence will feature expert-led presentations and networking opportunities, plus some special surprises to celebrate our society’s 50th anniversary.

We’re excited to connect with you at Booth #517, where our Qserve experts will be available to discuss regulatory challenges, share insights, and answer your questions. During the convergence, multiple Qserve speaker sessions and pre-conference workshops will take place. See more information below.

Session Details

Preconference Workshop: The Ins and Outs of the Commission's MDR and IVDR Targeted Revision Proposal (Day 1 of 2)

Qserve Speaker: Gert Bos

Monday, September 14, 2026 8:30 AM - 4:00 PM EDT

Topic: this workshop provides a comprehensive analysis of the proposed simplifications to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where we will systematically examine the proposal through key regulatory areas. On day 1 we will cover Foundations, Classification & Conformity Assessment 

Preconference Workshop: The Ins and Outs of the Commission's MDR and IVDR Targeted Revision Proposal (Day 2 of 2)

Qserve Speaker: Gert Bos

Tuesday, September 15, 2026 8:30 AM - 4:00 PM EDT

Topic: Topic: this workshop provides a comprehensive analysis of the proposed simplifications to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where we will systematically examine the proposal through key regulatory areas. On day 2 we will cover Evidence, Surveillance, Reception & What's Next

Pre Conference Workshop: Ethics in Action: Practical Tools for Navigating Regulatory Dilemmas

Qserve Moderator: Mindy McCann

Tuesday, September 15, 2026 8:30 AM - 4:00 PM EDT

Topic: This workshop will help define your own ethical code of conduct and clarify professional responsibilities when faced with ethical pressure. Industry experts representing manufacturing, consulting, and talent acquisition, will use real-world scenarios to explore how to recognize and navigate ethical dilemmas and decide when and how to speak up.

Session:  Small Manufacturers: Challenges and Lessons Learned 

Qserve Speaker: Robert Paassen

Wednesday, September 16, 2026, 9:15 AM - 10:30 AM EDT

Topic: The session will focus on regulatory pathways for medical device start-ups across both European and US markets, with an emphasis on lean approaches that enable market entry within one year.

  • Session: IVDR, Quo Vadis? Revising the In Vitro Diagnostics Regulation
  • Qserve Speaker: Gert Bos
  • Wednesday, September 16, 2026, 9:15 AM - 10:30 AM EDT
  • Topic: This session will support the better understanding of strategic impact the potential IVDR reforms and adjustments will have on your compliance efforts, and how they should feature in your regulatory strategy.
  • Session: MDR/IVDR State of Play
  • Qserve Speaker: Gert Bos
  • Wednesday, September 16, 2026, 1:00 PM - 2:00 PM EDT
  • Session: MDR Transition
  • Qserve Speaker: Gert Bos
  • Wednesday, September 16, 2026, 2:15 PM - 3:15 PM EDT

  • Session: Real-World Evidence: How to Move From Regulatory Buzzword to Valuable Asset 
  • Qserve Speaker: Bianca Lutters
  • Thursday. September 17, 2026, 9:15 AM - 10:30 AM EDT
  • Topic: Learn how to embed RWD collection from early product development through post-market activities. This session will focus on translating regulatory and clinical questions into actionable data strategies that support safety and performance evaluation, product claims, and health technology assessment needs without over-engineering or duplicating effort
  • Solutions Circle: Regulatory Challenges and Opportunities in Companion Diagnostics Clinical Trials
  • Qserve Spekaer: Nicolas Garrett
  • Thursday, September 17, 2026, 11:55 AM - 12:25 PM EDT 
  • Topic: the session will highlight common regulatory pitfalls encountered during CDx development and approval, as well as best practices for early regulatory engagement and cross-functional collaboration among clinical, regulatory, and development teams.
  • Will we see you in Charlotte this September?
  • Join our team and Immerse yourself in interactive discussions within a dedicated environment for regulatory affairs. For more information about the event and the full agenda please visit the RAPS Convergence event website.