Milestones that matter: new certifications and medical device support from Corti

Corti has registered its AI-based clinical assistant as a Class I medical device in the UK and is in the process of gaining EU medical device certification for products built on its API. This positions Corti uniquely among AI developers: not only offering powerful healthcare AI tools, but doing so within a framework that supports regulatory compliance across the UK and EU markets.

Unlike generic or open AI models, Corti’s technology has been developed under a full ISO 13485-compliant quality management system, incorporating ISO 14971 risk management principles and IEC 62304 software lifecycle standards. This ensures that both the software and its underlying processes meet key international benchmarks for safety, performance, and traceability.

For medical device manufacturers, this foundation offers significant advantages. By building on Corti’s API, partners can access AI functionality that is already aligned with many regulatory expectations - reducing the complexity and time typically required to meet compliance obligations.

Corti provides partners with structured support, including:

• A comprehensive documentation pack covering software architecture, risk files, clinical evaluation, testing reports, and other MDR-aligned evidence
• Clear, versioned release control of AI models to support post-market compliance and traceability
• Access to Corti’s regulatory experts and its specialist consultancy partner for guidance or local adaptation
• Willingness to share technical documentation with regulatory agencies and support audits as a critical supplier

Corti also supports manufacturers in navigating region-specific requirements. If a partner plans to launch in a market with unique demands, Corti can collaborate to close gaps and co-develop what’s needed to achieve compliance.

For manufacturers looking to integrate cutting-edge AI into their medical devices, without shouldering the full regulatory burden from scratch, this approach offers a faster, safer path to market.