Medical Devices

For us, quality and safety come first - we test and develop software in highly regulated markets, ensuring compliance with the most demanding international standards.
Software solutions for medical devices

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

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 13485, 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.

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Software Development
We work in each phase of the medical devices’ development lifecycle and deliver turnkey solutions moving up from requirements definition, through to design, implementation and testing and finishing with certification support.
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Cyber Security
Our approach to tackling the cyber security challenges facing the healthcare industry is two-pronged, focusing on supporting both the security of medical devices and systems, and the security of information.
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Verification & Validation
Our experience across a wide range of safety-critical domains allows us to deliver an effective and efficient V&V solution for increasingly complex and competitive medical device projects.
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Risk Management & Regulatory Affairs
We apply our experience with safety-critical applications to help our clients meet industry requirements in a cost-efficient way.
Brands that trust us
Centro Hospitalar e Universitário de Coimbra
Luís is a Principal Engineer in the medical devices industry. He has significant experience in developing and managing an array of projects, working with teams of various skills and competences. At Critical, he is responsible for actively driving and managing the technical side of medical devices projects. In his spare time, Luís enjoys sports, reading and is partial to watching interesting documentaries.
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Luís Coelho