menu
5th Medical Devices & SaMD: AI, Regulatory and Compliance
Early bird price

5th Medical Devices & SaMD: AI, Regulatory and Compliance

Where Devices and Software Meet Safety: Navigating AI, Regulation & Innovation in MedTech

calendar_month
Date10th – 11th Nov 2026
map
PlacePrague, Czechia
Price
from€1 099€1 799
calendar_month
Date10th – 11th Nov 2026
map
PlacePrague, Czechia

Advancing Compliance & Innovation in Medical Devices and SaMD

Join us for the 5th Medical Devices & SaMD: AI, Regulatory and Compliance Summit on 10-11 November 2026 in Prague. Gain practical tools to navigate global regulations (EU MDR, IVDR, FDA, AI Act), develop secure and compliant software, and align your QMS with evolving standards. Designed for professionals in regulatory affairs, software engineering, and quality systems, the #EdeviceS blends deep-dive insights with real-world case studies and peer exchange. 

Key points

  • Stay up to date on global regulations: EU MDR, IVDR, FDA, and the evolving AI Act for medical technologies.

  • Understand the full lifecycle of SaMD development: from design control and software architecture to regulatory approval.

  • Learn how to align your Quality Management System (QMS) and technical documentation with AI and software-specific standards (IEC 62304, ISO 14971, ISO 13485).

  • Apply risk management principles across the development lifecycle using real-world examples and engineer-driven workflows.

  • Navigate PMCF strategies, SSCP requirements, and clinical evaluation reports to maintain compliance under MDR.

  • Understand the classification of AI-powered medical devices, how to meet transparency and bias requirements, and prepare for conformity assessments.

  • Build secure, connected devices that meet cybersecurity regulations and integrate data privacy by design.

  • Learn strategies to streamline regulatory submissions through automation, structured data, and AI-assisted clinical evaluations.

  • Address challenges with combination products, borderline classifications, and notified body feedback.

  • Exchange best practices with peers in software engineering, regulatory strategy, and product development during interactive sessions and panels.

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:

  • Regulatory Affairs & Regulatory Strategy
  • Quality Assurance (QA) & Quality Control (QC)
  • Software as a Medical Device (SaMD)
  • Artificial Intelligence & Machine Learning in MedTech
  • Product Development & Innovation
  • Systems & Software Engineering
  • Clinical Evaluation & Clinical Affairs
  • Compliance, Risk Management & Safety
  • Research & Development (R&D)
  • Medical Device Design & Engineering

5th Medical Devices & SaMD: AI, Regulatory and Compliance

Where Devices and Software Meet Safety: Navigating AI, Regulation & Innovation in MedTech

calendar_month
Date10th – 11th Nov 2026
map
PlacePrague, Czechia
Price
from€1 099€1 799

FAQ

Your questions answered here.

How can I get more information?

We’d love to help you make the most of the summit! You can request the summit brochure or contact our team directly using the details below. Our team is happy to answer any questions and guide you in planning your participation.

What networking opportunities are available?

Our events are designed to spark genuine connections. In-person participants benefit from structured formats like speed networking sessions, as well as informal interactions during the exhibition, coffee breaks, lunches, and networking dinners — where all participants are invited.

Virtual and hybrid attendees can also connect through our event platform, which supports chat, meeting requests, and live Q&A with speakers and peers.

How can I register for an event?

You can register online via each event’s dedicated page. Once submitted, you’ll receive a confirmation and invoice by email. For special requests, feel free to contact our team directly to hello@etapahub.com or the contact person noted at the designated event page.

Will I receive presentation slides after the event?

Yes — all registered participants receive access to post-event materials, including authorized speaker presentations (subject to permission), and other relevant documents.

If you’re unable to attend in person, a documentation package can be purchased separately. For selected hybrid events, we also offer a recording package with on-demand access to sessions.

Will I get a certificate of attendance?

Yes. All in One & Standard packages include attendance provide a digital certificate.

What language will the summit be conducted in?

All summit sessions will be presented in English. While translation services are not provided, we welcome attendees from around the world and encourage everyone to join the discussions and networking opportunities.

For any event assistance please contact

Irina Andres
Irina AndresSales and Booking Specialist
mailirina@etapahub.com