Regulatory support for AI-enabled healthcare software, SaMD and digital health technologies

Determining the correct medical device product classification(s) and regulatory approval path, across multiple territories if required, is one of the most important early-stage decisions for software and AI developers. Decisions made during product definition often determine the entire regulatory journey. We help organisations understand whether a product falls within the medical device regulations and what that means for future evidence, documentation and quality system requirements.

We create Regulatory Strategy documents tailored to each client’s device, defining what will be required for the device to achieve and maintain regulatory approval and access its intended markets, including anticipated timelines and costs, where required.

MedTech and SaMD software development teams are familiar with agile development, but less familiar with medical device and diagnostics regulatory expectations. We help bridge that gap by determining qualification and classification, software risk classification and risk management requirements, translating software development activities into the documentation and evidence frameworks expected by regulators. Our approach aligns with internationally recognised standards including ISO 13485 (quality management systems), ISO 14971 (risk management) and IEC 62304 (medical device software lifecycle processes), helping organisations prepare regulatory submissions that meet regulators’ requirements and maintain compliance throughout the product lifecycle.

AI creates challenges that do not exist in traditional software. Questions around training data, model behaviour, clinical validity and, where ML technologies are relied upon, performance drift can all influence how regulators assess an AI-enabled digital healthcare or SaMD product. We help organisations understand those expectations and prepare the evidence needed to support regulatory submissions and product lifecycle requirements.

Effective quality systems provide the foundation for regulatory compliance and an essential framework for ensuring patient safety and the quality and effectiveness of software and AI devices. We support organisations in implementing and maintaining quality management systems aligned with ISO 13485 and applicable best practice software development controls and lifecycle requirements, helping ensure compliance is embedded throughout product development, validation and post-market activities.

MedTech regulatory submissions depend on more than a completed technical file. Reviewers need to understand how the technology was developed, whether that is an offline medical device or an AI-enabled or SaMD product, and how performance has been demonstrated and risks are being managed throughout the product lifecycle. Abingdon AI & MedTech assists with technical files, clinical and performance evaluation evidence strategies, software technical documentation, risk management files and submission packages to support regulatory reviews and market approvals.