Key Learning Objectives
14:30 - 15:00 From Compliance to Risk: Rethinking Medical Software Testing
Compliance driven testing creates a comforting illusion of safety, but it rarely reflects how software behaves in real clinical workflows.
If you look at FDA recalls and field data, the real failures happen in end-to-end scenarios, system interactions, and situations no one explicitly scripted.
This talk shows how to shift testing toward risk, meaning testing what truly matters for patient safety by validating real user journeys and system behaviour.
Presented by: Tobias Müller, Managing Director, progile AG
15:00 - 15:30 Decoding Essential Performance in IEC 60601-1: The Hidden Difference That Could Make or Break Your Medical Device
In this session, we’ll cut through the confusion around Essential Performance in IEC 60601-1, a critical yet often misunderstood concept in medical device compliance.
You’ll learn how to distinguish Essential Performance from Basic Safety and understand its broader role in compliance, particularly in EMC immunity testing.
We’ll also explore why IEC TS 60601 4-2 highlights the importance of ‘performance that is not essential for safety’. Leave with actionable insights to apply immediately in your work.
Presented by: Beat Keller, Managing Director, Regulatory Expert, SMDC Swiss Medical Device Consulting GmbH
15:30-16:00 Testing the untestable: Computer Software Validation of AI functionality
AI fundamentally shifts software testing in medical devices from deterministic verification to data-driven, probabilistic validation.
It requires integration into a continuous PDCA cycle, combining black-box testing, statistical evaluation, and risk management.
In this session we will discuss how to validate AI of unknown provenance, where safety can be ensured through strict use limitations and continuous post-market monitoring rather than complete pre-market verification.
Presented by: Regina Geierhofer, Chair of CLC TC62, Regulatory Affairs Professional
16:00 - 16:30 The interconnected eQMS: Addressing (and eliminating?) 'The work around eQMS work'
Disconnected processes in a traditional eQMS create unnecessary "work around the work", adding inefficiency, risk, and frustration for users.
This talk explores how an interconnected eQMS can streamline workflows, reduce manual effort, and potentially eliminate administrative burden altogether by intelligently leveraging information that is already present.
Presented by: Karl Larsson, Managing Director, Aligned AG
Time and Place
- Date: Tuesday, May 5th
- Time: 14:30 - 16:30 CET
- Live Streamed from the Aligned HQ. The Teams link is on the Linked In Event page.
Presentations are held in English.
Target Audience
This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.
About Aligned AG
Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.
