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.
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.
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.
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.
