What's this all about?

Manufacturers of AI/ML-based medical devices must technically verify and clinically validate the performance and safety of their AI/ML system. The regulatory requirements are manifold, unclear, heterogeneous, open to interpretation, and in constant flow.

We have compiled and structured the essential best practices and techniques for AI/ML development and validation in our ML validation playbook. Take a look to get an idea of what the notified bodies within the realm of the MDR and the FDA auditors expect.

For medical device manufacturers (as well as some 20 other regulated markets) the upcoming AI act will increase their regulatory load while decreasing legal uncertainty. For a number of other markets, the AI act will mean regulation of a so far unregulated market. In practice, this boils down to establishing a quality management system and a risk management system, and drawing up comprehensive technical documentation, very similar to what is expected from medical device manufacturers.

Whether you are a medical device start-up, a weathered manufacturer that introduces AI/ML technology into their product, or a non-medical AI/ML provider wondering if and how the AI act applies to them, we can help you find the best way to certification and placing your products onto the market.

Our experience includes classification of your AI/ML-based product, adapting your pre-existing QMS for AI/ML or helping you establish a new QMS, compiling sound and readable technical documentation, and helping you with the clinical validation of your product.