AI takes healthcare by storm: understanding how to safely launch devices in the UK, US and EU

A new whitepaper by regulatory experts IMed Group and life science software developers Firefinch Software

Oxford, 12^th February 2026 – IMed Group, a leading provider of regulatory consultancy services to the global medical and health technology industry, and Firefinch Software, software  a leading life sciences software development agency based in Edinburgh today release a free new whitepaper, Smart Code, Safe Care: Navigating AI Acceleration in Regulated Medical Devices, supporting businesses launching or wishing to maintain software or AI-powered devices on key markets such as the UK, US and EU. 

Whether it’s university spinouts with an innovative algorithm that could improve the lives of patients directly, or established corporates integrating a new AI component into an existing physical device, there are a variety of key considerations to ensure that each solution can enter and remain in its target market whilst maintaining regulatory adherence.

IMed Group and Firefinch have combined their expertise to help businesses of all sizes understand the ever changing technical and regulatory environment. Navigating international regulatory variations is a key component of project success, whilst each regulator prioritises patient safety in their region, guidance and documentation requirements may not be consistent.

As the compliance map keeps evolving, digital medical device manufacturers must adapt by integrating new skills and processes into their team. This environment places unprecedented demand on organisations developing digital medical devices. Teams must develop or acquire new cross-disciplinary skills that bridge software engineering, product development, clinical risk management, cybersecurity, data science, and regulatory compliance. They must integrate ethical data management systems, implement robust AI governance, navigate ISO requirements, validate systems that behave probabilistically, and adapt to shifting regulatory norms across different geographies.

This newly developed white paper delves into how different digital components relate to a medical device’s functionality and classification. IMed’s regulatory experts also offer an overview of how the UK, the US and Europe regulate Software as a Medical Device (SaMD) and AI-powered medical technology, highlighting consistencies and differences.

“We’re continuing to provide our insights to the market in the form of expert commentary and guidance as we understand that lack of clarity is one of the key obstacles SaMD and AI device businesses face today. We’re delighted to have been able to combine the knowledge of life sciences software development teams at Firefinch Software with that of our regulatory specialist to support both established businesses and startups navigate this exciting new phase,” comments Jonathan Ripley, Managing Director at IMed Group.

“The digital medical device market is quite literally learning on the job,” comments Ruaidhrí Primrose, Director at Firefinch. “We're seeing an increase in partnerships between internal medical device developers and external teams who are equipped to navigate the nuanced regulatory landscape concerning the use of AI and its medical device applications. Teams like ours are the link that can translate innovative scientific workflows into sophisticated, functional software. Our feedback suggests these blended teams often provide clients with the confidence their project adheres to regulatory requirements and avoids costly rework whilst crucially protecting patient safety and privacy at all times.”

The whitepaper is available free of charge at www.imedconsultancy.com.

About IMed Group

Founded in 2012, IMed Consultancy offers a wide range of expert services to the global medical and health technology industry. We support medical device and in vitro medical device manufacturers to drive innovation, improve patient care and outcomes worldwide, providing assistance through all stages of the product lifecycle: from concept and design through clinical studies and post-market surveillance. 

IMed Consultancy’s team of highly skilled and experienced medical regulatory professionals offers an outstanding yet accessible global regulatory service. We are committed to our team, to innovation, to our client’s growth and success, to the health tech community, and patients. We build trusted relationships by offering agile solutions and education to advance healthcare innovations and adapting flexibly to client needs as we strive to stay ahead of industry trends, investing in developing our knowledge and seeking new opportunities to deliver value to the sector. With over 70 years of combined hands-on problem-solving expertise, our remit is truly global, ensuring that client devices are successfully launched and maintained in total compliance in the UK, EU and internationally. 

For more information visit www.imedconsultancy.com 

About Firefinch

Firefinch Software develops custom software for life science companies. Our expert-led development team combines deep scientific domain knowledge with regulatory compliance and strategic insight to help you build the right product, ready to scale.

Strong domain expertise. Firefinch deliver solutions in medtech, biotech and medical devices and with companies ranging from start-ups to large multi-nationals. We take pride in delivering excellent client outcomes while strengthening clients' core capabilities.

Your software team for hire. Firefinch can provide an entire cross-functional product team or can embed senior consultants with existing teams to strengthen their delivery capability. All projects are supported directly by a senior consultant and offer access to the skills of the entire team no matter the size of the project.

Built for long-term success. The Firefinch team adapt to the client's needs. From the code to control a device through to cloud platforms for interacting with your data, we are experts at end-to-end solutions aimed at both external customers and internal business users.