Medical Devices

When lives depend on the software, there's no room for compromise — we build, test, and certify medical device software to the world's most demanding standards.

Medical Devices

Technology is at the heart of how we look after people

Medical device software failures aren't just technical problems — they're patient safety events. That's why we treat every line of code as a clinical decision, applying rigorous standards across the entire development lifecycle — from architecture and design through verification, validation, and regulatory submission.

We work within the frameworks that matter most to regulators and manufacturers: MDR, HIPAA, IEC 62304, ISO 13485, ISO 14971, IEC 62366, IEC 60601, and 21 CFR Subchapter H, among others.

Domain offer

Engineering software across every medical device domain

From connected diagnostics to life-critical treatment systems, we support medical device manufacturers across every major technology domain — bringing safety-critical engineering expertise wherever the stakes are highest.

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Digital Health & Interoperability

Connected health platforms, patient apps, and clinical decision support — built to regulatory standards and engineered to scale.

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02
Diagnostic & Imaging

Precision software for diagnostic and imaging systems — where the data clinicians rely on has to be right, every time.

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Therapeutic & Treatment Delivery

Embedded software for infusion systems, radiation therapy, and beyond — where correctness isn't a goal, it's a requirement.

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Monitoring & Support

Reliable software for patient monitoring and clinical support tools — because a missed reading can have serious consequences.

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05
Laboratory Solutions

Software for in-vitro diagnostics, lab information systems, and automated environments — built with the same rigour.

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Trusted by leading companies worldwide

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Our solution

Our medical devices solutions cover the full system lifecycle

From requirements and architecture to certification and post-market compliance — our solutions cover every stage, every standard, and every domain that matters in medical device development. Whether you're bringing a new device to market or evolving an existing one, we have the expertise to get you there safely and on time.

Systems & Software Development

From firmware and bootloaders to cloud services — we develop embedded and application-level software for Safety Class C systems, compliant with IEC 62304, IEC 60601, and IEC 82304.

Testing & Verification

Rigorous software and hardware verification, HIL testing, and AI-powered coverage — delivered by ISTQB-certified teams aligned with ISO 13485, ISO 14971, and FDA 510(k) guidance.

Quality Assurance & Regulatory Affairs

Design control, traceability, technical files, and audit support — covering ISO 13485, ISO 14971, FDA 21 CFR Part 820, MDR, GDPR, and TÜV certification.

Cybersecurity

Threat modelling, SBOMs, penetration testing, and incident response — integrated from day one, aligned with IEC 81001-5-1 and FDA guidance, so your device can reach the market.

Digitalization & Interoperability

Real-time communication and digital transformation through SDC, HL7, DICOM, FHIR, and beyond — enabling digital twins, predictive maintenance, and data-driven decision support.

Artificial Intelligence

AI for diagnostics, workflow automation, and patient monitoring — developed with explainability and traceability built in, aligned with IEC 62304, ISO 14971, and the EU AI Act.

Success stories

Advancing medical devices together

Our medical device success stories reflect long-term partnerships built on shared responsibility, deep technical expertise, and a commitment to delivering safe, reliable, and compliant systems. From connected devices to complex regulated environments, we work side by side with our partners to support innovation and improve patient outcomes.

ISO 13485 Company and Device Certification

Learn how ISO 13485 certification and QMS implementation support medical device compliance and CE marking. Discover how expert consultancy ensures regulatory alignment, reduces audit risk, and accelerates time-to-market.

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Resources

Our medical devices knowledge hub

The latest thinking on medical device software, regulation, cybersecurity, and digital transformation — from the people who build it.

White Papers

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An (Almost) Hassle-Free Digitalization Journey

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Medical Devices
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Enabling Medical Device Interoperability

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Medical Devices
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Meeting Regulatory Demands in Medical Device Development

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Medical Devices
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Post-Market Surveillance in Medical Devices

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Medical Devices
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Building Cybersecurity from Manufacturer to End User

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Medical Devices
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The Role of Software in Medical Device Failures

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Medical Devices

Guides

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A Readiness Guide to SDC and Connected Healthcare Ecosystems

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Medical Devices

Webinars

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Navigating FDA and EU MDR/IVDR Compliance

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Medical Devices
Certification & Standards

Operating at the highest industry standards

Medical device software demands rigorous compliance with international standards covering safety, quality, and risk management. Our work is aligned with the recognized frameworks that govern the development, verification, and certification of safety-critical medical software and systems.

IEC 62304

Medical device software lifecycle processes

The foundational standard for medical device software development — covering planning, development, maintenance, and risk management.

ISO 13485

Quality management systems for medical devices

The global benchmark for quality management in medical device development and manufacturing.

IEC 60601

Safety and performance of medical electrical equipment

Defines safety and performance requirements for medical electrical equipment used in clinical environments.

ISO 14971

Risk management for medical devices

The framework for identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle.

IEC 82304

Health software product safety

Addresses safety requirements for health software products running on general-purpose computing platforms.

Get in touch

Let’s build your next medical device together

Talk to our medical devices team, and let's get started.

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Ana Rita Silva

Business Development (EU)

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Luís Coelho

Business Development (EU)

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Philipp Roessler

Business Development (USA)

Events

Join us at upcoming industry events

We regularly attend the leading medical devices and software engineering events. Come and meet the team, see our work up close, and talk to the people who build it.

21-23 April • Berlin, Germany
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DMEA - Connecting Digital Health

Attending DMEA in Berlin? Find us at the OR.NET booth — we'd love to meet you.

News

Latest from medical devices

Insights, news, and perspectives from our medical devices team.

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BlogMedical devices

Industry Voices: The Regulatory Maze of MedTech, Insights from Amanda Maxwell

Explore expert insights from Amanda Maxwell on EU and UK MedTech regulations, MDR/IVDR challenges, Brexit impacts, and opportunities for innovation in a complex regulatory landscape.

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BlogMedical devices

Interoperability: From Buzzword to Backbone

Learn how Service-oriented Device Connectivity (SDC) and open standards like IEEE 11073 enable medical device interoperability, improving healthcare efficiency, safety, and innovation.

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BlogMedical devices

The Future of Healthcare Connectivity: Meet the Interoperability Bridge

Healthcare Connectivity Solution: Interoperability Bridge by Critical Software

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NewsMedical devices

Critical Software & SKAN AG: Transforming Automation in Aseptic Processing Through Agile Innovation

Discover how Critical Software and SKAN AG are transforming pharmaceutical automation through agile practices, digital transformation, and innovative aseptic processing solutions.

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BlogMedical devices

No Cyber, No Sales: Regulatory Demands in Medical Device Development

Learn how cybersecurity is becoming essential for medical device compliance with FDA and EU MDR, including standards, SBOM, and secure development practices.

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BlogMedical devices

Critical Software Joins OR.NET e.V. to Advance Medical Device Interoperability

Critical Software joins OR.NET e.V. to support open standards like SDC and advance secure, interoperable medical device connectivity in healthcare systems.

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BlogMedical devices

Lisbon’s MedTech Forum 2025: A Glimpse into the Future of Healthcare Innovation

Explore key insights from MedTech Forum 2025 in Lisbon, covering AI, interoperability, global regulation, and the future of digital healthcare innovation.

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BlogMedical devices

Memory Safety in Medical Devices: Understanding and Mitigating Critical Vulnerabilities

Learn how to address memory safety vulnerabilities in medical devices with proactive cybersecurity strategies, SBOMs, and RASP to ensure patient safety and compliance.

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NewsMedical devices

Critical Software Achieves ISO 13485 Certification

Critical Software achieves ISO 13485 certification, demonstrating excellence in quality management systems for medical device development and regulatory compliance.

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NewsMedical devices

Why Medical Device UX Design Is Critical

Learn why UX design is essential in medical devices, how poor usability impacts patient safety, and how standards like IEC 62366 and MDR shape safer healthcare solutions.