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.

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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 MDR, HIPAA, IEC 62304, ISO 13485, ISO 14971, IEC 62366, IEC 60601 series, 21 CFR Subchapter H, among many others inform every step we take in making medical devices safe.

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System development

We design and optimise complex system architectures using MBSE and standards such as ISO 15288 and IEC 60601. From requirements engineering through to subsystem specification and integration, we ensure safety, performance, and compliance across medical and pharmaceutical platforms — supporting both new developments and the evolution of legacy systems.

Cyber Security

Cybersecurity is integrated into the development process from day one. We work with IEC 81001-5-1, IEC 60601-4-5, IEC 62443-4-1 and FDA guidance to support threat modelling, SBOMs (with an end-to-end solution), penetration testing, and incident response. This enables manufacturers to meet MDR Annex I (17.4), the requirements for a 510(k) submission, and other global obligations — because without cybersecurity, devices cannot reach the market.

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Quality Assurance & Regulatory Affairs

We support quality assurance through design control, traceability, and documentation. Our work complies with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and MDR. This includes preparing technical files, supporting audits, and ensuring post-market compliance. Our team also brings expertise in regulations such as GDPR and TÜV certification.

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Artificial intelligence

AI is applied to support diagnostics, automate workflows, and monitor patients. Solutions are developed with ISO 13485, ISO 14971, and IEC 62304 in mind, and in alignment with emerging regulations from the FDA and the EU AI Act. The emphasis is on explainability, traceability, and integration into regulated environments — with safety and performance always as priorities.

Software Development

We develop embedded and application-level software in accordance with standards such as IEC 60601, IEC 62304, and IEC 82304. From board support packages, firmware, bootloaders, and embedded operating systems to mission-critical business logic and cloud services. Using V-Model approaches, we deliver traceable, audit-ready solutions for Software Safety Class C systems, from requirements through to deployment.

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Verification & Testing

We ensure product quality through rigorous verification and testing of both software and hardware, including User Interface and Hardware-in-the-Loop (HIL) setups. Our System Validation Facility (SVF) accelerates automated testing of medical devices, enhancing efficiency and reliability. We leverage AI-powered testing solutions to improve coverage and detect anomalies more intelligently and rapidly. All activities are aligned with ISO 13485, ISO 14971, and FDA 510(k) guidance. Our ISTQB-certified teams bring proven expertise in critical systems.

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Interoperability & Digitalisation

We integrate your system landscapes using standards such as SDC, SDPi, AAS, IHE, HL7, DICOM, and FHIR. Our standards-based approach supports real-time communication and drives digital transformation through interoperable platforms that enable digital twins, predictive maintenance, process automation, and data-driven decision support.

User Interface Design

Interfaces are designed to be safe, intuitive, and compliant with IEC 62366 and FDA human factors guidance. The process involves design thinking, workshops, and usability testing. From Class III monitors to image correction systems, the focus is on minimising user error and improving clinical outcomes — always in close collaboration with real users.

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Centro Hospitalar e Universitário de Coimbra

Medical Devices

Engineering safety-critical software for life-saving technology

We develop and test software for medical devices that improve lives and meet the highest standards of safety, security, and compliance. From embedded systems to mobile-connected Class III devices, we support the full lifecycle: requirements, development, verification & validation, and regulatory documentation. Our teams work to IEC 62304, ISO 14971, ISO 13485, and IEC 60601, ensuring readiness for FDA and MDR submissions. Cybersecurity is embedded from day one, aligned with IEC 62443 and FDA premarket guidance. Whether you're building a new device or modernizing legacy systems, we help you deliver safe, secure, and certifiable solutions — on time and at scale, saving time and reducing overall costs.

Life Sciences

Digital platforms for data-driven discovery

We help life sciences organizations accelerate innovation through secure, compliant, and interoperable digital systems. Our solutions span LIMS integration, clinical data platforms, and AI-powered analytics — all designed with GxP, 21 CFR Part 11, and ISO 27001 in mind. We bring deep expertise in software validation, data integrity, and cybersecurity, ensuring your systems are audit-ready and future-proof. From early-stage research to real-world evidence, we enable digital transformation that’s traceable, scalable, and built for impact.

Pharma

Smart, compliant systems for modern pharma

We support pharmaceutical companies in building and validating digital ecosystems that meet the demands of modern drug development. From GAMP 5-aligned software to AI-driven pharmacovigilance tools, our teams deliver solutions that are secure, validated, and compliant with global regulations and practices (GxP, FDA 21 CFR Part 11, ALCOA+, EMA, WHO). We specialize in digitalizing legacy systems, integrating cloud-native platforms, and automating regulatory workflows using NLP and machine learning. Whether it’s manufacturing, clinical trials, or regulatory submissions, we help you move faster, stay compliant, and innovate with confidence.

Ana

Rita

Ana Rita (who prefers to be called Rita) has been our Business Development Manager for the Medical Devices and Lifesciences European market since the beginning. She manages all customer relationships in this sector, including potential new clients and partners. On a personal note, Rita loves attending concerts and movies, traveling as often as she can with family or friends, and is a passionate advocate for animal welfare.

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Philipp

Roessler

Philipp leads Critical Software’s Boston office and drives the growth of its Medtech business in North America, expanding its presence and building strategic partnerships. Outside of work, he enjoys haidong gumdo, chess, and football—both playing and coaching. A dedicated youth football coach for over a decade, he’s also introduced all three of his sons to the game.

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Sérgio

Pereira

Sérgio is a Principal Engineer with extensive experience in the medical devices and life sciences industries. He has a proven track record of developing and managing diverse projects while collaborating with multidisciplinary teams. At Critical, he leads the technical aspects of medical device projects, ensuring seamless integration and precise definition of software and hardware specifications. In his spare time, Sérgio enjoys cycling and music.

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