Join us for this special RAPS workshop at the Florida Medical Device Symposium to explore the practical, real-world applications of AI in QA/RA, including how to improve efficiency without compromising compliance, avoid common risks, and apply AI in ways that are defensible and audit-ready. AI isn’t replacing QA/RA — it’s becoming one of its most powerful tools. The workshop will also provide important updates on EU MDR/IVDR & UKCA, including new proposals aimed at reducing burden and increasing flexibility. You may register for the May 7th RAPS workshop only ($45) or enjoy the full two-day conference at a special discount using the promo code: “RAPS”
BSI:
EU MDR/IVDR & UKCA: What’s Changing and What It Means for You
EU MDR and IVDR implementation has proven more complex and burdensome than anticipated — and significant reforms are now being proposed to address these challenges.
This session will go beyond a simple regulatory update to focus on what these changes mean in practice for manufacturers. Topics will include proposed efforts to simplify requirements, potential down-classification of certain devices, increased flexibility in evidence expectations, and evolving post-market and organizational requirements.
We will also touch on the current state of UKCA and how it continues to align — and diverge — from EU frameworks.
Attendees will leave with a clearer understanding of:
- What changes are being proposed
- What is likely to impact their products and timelines
- How to begin preparing now to reduce risk and avoid rework
AI:
The Deployment of Practical, Compliant, and Real-World AI
Artificial Intelligence (AI) is already being used inside regulated companies — the real question is whether it’s being used safely and securely.
AI isn’t replacing QA/RA — it’s becoming one of the most powerful tools available to them. But in regulated environments, how you use it matters just as much as whether you use it.
This session will focus on practical, real-world applications of AI in QA/RA, including how teams are:
- Using AI to improve efficiency without compromising compliance
- Avoiding common risks that can impact quality systems and regulatory standing
- Applying AI in ways that are both defensible and audit-ready
You don’t need to choose between innovation and compliance.
Just as spreadsheets transformed engineering, AI is transforming how regulated teams work — when implemented correctly.
Join us to learn how to leverage AI confidently, safely, and securely within your organization.
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