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Smart Code, Safe Care: Navigating AI Acceleration in Regulated Medical Devices

Smart Code, Safe Care: Navigating AI Acceleration in Regulated Medical Devices

Building AI into your medical device? Here’s what your software partner needs to get right
For ISO13485 medical device manufacturers taking their first serious steps into AI-enabled software, the path from prototype to compliant, market-ready product is rarely as straightforward as it first appears. The software development challenges that come with building a Software as a Medical Device (SaMD) are distinct, numerous and easy to underestimate.

Why AI can’t write your software

Why AI can’t write your software

We attend events across Europe and the US, and one of the most common general questions we get is about the impact of Generative AI - when should...

Cybersecurity – Secure by Design

Cybersecurity – Secure by Design

When the Firefinch team build software for our clients, we know that they need security to be taken seriously – whether the software is for a...

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