Western Canada Chapter Virtual Event: AI Literacy for MedTech: Regulatory Augmented Intelligence

This workshop focuses on integrating the EU AI Act into MDR/IVDR by unifying QMS, documentation, and risk management, while also demonstrating how AI tools can handle regulatory data and automate compliance

8:30am – 11am MDT June 26, 2026 + Add to calendar

Many companies struggle to align the EU AI Act with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), as each framework focuses on different aspects AI Act on data governance and transparency, and MDR/IVDR on safety and performance.

The most effective solution is to integrate AI Act requirements into existing documentation and quality systems to avoid duplication.

This workshop demonstrates how to do this by embedding AI obligations into QMS, managing both safety and fundamental-rights risks, and creating unified technical documentation, while also guiding organizations to adapt roles and governance for successful AI integration.

Learning Objectives

Obtain a clear understanding of the definition and high-level insights into AI technology and what AI Literacy means.
Develop skills to leverage AI tooling in regulatory workflows and achieve higher productivity, while using the tools responsibly.
Obtain the two key perspectives on AI in devices: that of the manufacturer and that of the user (who also has obligations).
Understand how the EU AI Act aligns with MDR and IVDR requirements and how it differs the approach the FDA takes to regulating AI.
Identify key overlapping obligations for QMS, data governance, human oversight, and risk management between the AI Act and MDR/IVDR.
Integrate AI Act requirements into existing MDR/IVDR quality systems to streamline compliance and avoid duplication: work with the two intersecting regulatory regimes.
Prepare unified technical documentation that meets both AI Act and MDR/IVDR expectations, including data, model, and lifecycle controls.
Learn what demands the AI Act sets for data and how data governance needs to be applied to achieve compliant access to datasets, logs, and model artefacts.
Strengthen organizational readiness by adopting AI-driven compliance tools and defining new roles for AI governance and oversight.

Hands-on assignment

Between the plenary teaching parts of the workshop, participants will be given a case study to work on, for medical devices and AI. The use of AI tools for this assignment is encouraged.

Who Should Attend?

Regulatory affairs and quality assurance professionals
Data scientists, software engineers
Clinical investigators
MedTech leaders involved in AI integration and governance

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.