Software and AI Validation
Software and AI in Medical Devices
Over the past 30 years, software has become the core of virtually every technological application.
In the medical field, the link between software and medical device safety has become inseparable. The EU MDR 745/2017 addresses both standalone and embedded medical device software in much greater detail than previous regulations, introducing dedicated classification rules that increase the risk class of many standalone software applications.
Recently, the use of Artificial Intelligence (AI) has become widespread in many Medical Device Software (MDSW)applications, further raising the regulatory challenge to demonstrate performance and safety for products that integrate or rely on AI.
Our team includes experts with decades of international experience in medical software validation, with successful assessments by authorities such as the FDA, and proven experience in registering AI-integrated software under MDR.
Maytal can support companies from the early stages of software design to:
Define the software risk level
Provide guidance to designers on the software life cycle in compliance with IEC 62304
Define software requirements
Establish appropriate criteria and controls for selecting datasets to train AI algorithms
Define strategies for integrating AI into MDSW
Plan testing and execute validation, including critical review to ensure full compliance
We provide practical solutions that enable R&D teams to produce the necessary documented evidence to support software validation.
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