AI in Medical Devices
Artificial Intelligence is transforming the medical device industry, driving innovation in diagnostics, treatment optimisation, and clinical decision support. Yet, with this advancement comes increasing regulatory scrutiny. The convergence of the Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the forthcoming EU Artificial Intelligence Act introduces a dual compliance environment that demands both technical robustness and ethical accountability. Manufacturers must now demonstrate not only clinical performance and safety but also algorithmic transparency, data governance, and lifecycle control. For organisations integrating AI into medical technologies, success depends on establishing disciplined frameworks that align technological innovation with evolving regulatory expectations.
Our AI in Medical Devices services provide comprehensive support for the regulatory, technical, and governance dimensions of AI-enabled device development. We begin with an AI readiness assessment, evaluating how existing systems, data sources, and documentation align with the classification and risk-based requirements of both the MDR and the AI Act. This diagnostic phase identifies regulatory obligations, determines whether the AI system qualifies as a high-risk application, and establishes the appropriate conformity assessment pathway.
We then assist in developing and implementing governance frameworks that ensure full traceability and accountability across the AI lifecycle. This includes defining data management processes, version control for algorithms, change documentation, and validation protocols for model training and retraining. Our methodologies draw on established standards such as ISO/IEC 23894 for AI risk management, ISO 14971 for medical device risk assessment, and emerging guidance from the European Commission and MDCG on AI and software qualification.
Data governance forms a central element of compliance. We help clients implement quality controls for training and testing datasets, ensuring that data are representative, unbiased, and documented with appropriate provenance. Our approach integrates FAIR (Findable, Accessible, Interoperable, Reusable) data principles and GDPR compliance to guarantee that data processing meets both ethical and legal standards. By establishing clear documentation of data sources, preprocessing steps, and validation outcomes, we enable manufacturers to demonstrate transparency and reliability in algorithmic performance.
Model validation and performance evaluation are structured to withstand regulatory review. We support the design of testing protocols, statistical verification methods, and continuous performance monitoring systems that ensure stability and clinical relevance across product iterations. For adaptive algorithms and continuously learning models, we define control mechanisms that maintain conformity while allowing for iterative updates under controlled conditions.
Cybersecurity and human oversight are integrated into every compliance framework we design. We assist in defining safeguards that protect against unauthorised access, data manipulation, and system failures, while ensuring that human users retain the ability to interpret and override AI-generated outputs. This balance between automation and oversight is fundamental to both MDR compliance and AI Act conformity.
Artificial intelligence in healthcare holds enormous potential but realising that potential requires disciplined compliance and governance. Our services equip organisations to deliver innovative, trustworthy, and regulator-ready AI-enabled medical devices.
For further information on how our AI in Medical Devices services can support your compliance and governance objectives, please contact our digital health and regulatory affairs team.
