Technology is at the heart of how we look after people.

We depend on medical devices to care for people in their most vulnerable moments. Patient monitoring systems, life support machines, defibrillators, implants and more all rely on increasingly complex software to work. These devices are becoming ever-more interconnected and more intelligent. Areas such as cyber security, artificial intelligence (AI) or user experience design (UxD) are revolutionising patients’ interaction with healthcare.

With little to no margin for error, the stakes could not be higher - so healthcare professionals need to trust the technology they are using. 

Our experience across a wide range of safety-critical domains means we put quality and safety at the heart of everything we do. Solutions design, software development, verification and validation activities and deployment – whatever the task, we apply the strictest standards throughout the entire development lifecycle as set by bodies such as the FDA and the European Commission (EC). Standards like the MDR, the IEC 62304, ISO 14971, IEC 62366, IEC 60601 series, the 21 CFR Subchapter H, among many others inform every step we take in making medical devices safe.
Medical Devices
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It starts with

a single cell.

Working with Coimbra Genomics, we developed a system linking genomic knowledge and medical practice. This tech will allow medical professionals to make decisions based directly on a patient’s genetic makeup, personalising and significantly improving their healthcare.

Checking the health of medical devices.

A staggering one in three medical devices have suffered recalls because of failures – with software being the most significant factor. We work to make sure this doesn’t happen, ensuring safer and more effective prevention, diagnosis, treatment and rehabilitation of illness and disease.

Here are just a few of the clients we work with

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What we do for the 

medical devices industry

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We’ll be happy to help you in any way we can.

If you’d like to get in touch, please fill in the form or drop us an email at info@criticalsoftware.com.