Industries
Medical technology
In a regulated setting the deliverable is not the function but the demonstrable function.
IEC 62304
What is technically different in this industry
Evidence before speed. What is not documented does not exist in a regulated setting. Test cases, logs and traceability are not overhead but part of the product — which matches how we work anyway.
IEC 62304 shapes the architecture. The standard requires a software safety classification and development and maintenance planning aligned to it. That acts directly on how the software is cut: what is safety-relevant is isolated and evidenced separately.
Safety-critical updates. An update to an approved device is a procedure with its own process, not a deployment.
Cyber security as an approval topic. Requirements for hardening and vulnerability management have become part of the regulatory picture.
What we have done here
For a medical laser system we developed, tested and documented the planning and treatment interfaces — extended the associated test tools, carried out unit tests and code reviews, and implemented safety-critical updates and cyber security requirements. The work used C++, Python, Qt, Boost and CMake in a toolchain of Jenkins, DOORS, Fisheye/Crucible and SVN.
Related services
Software development & architecture
We design architectures that stay testable in isolation and independent of frameworks, and we implement them — from embedded and desktop through backend services to web and mobile. Clean Architecture · Microservices · Event-driven · API-first · arc42Security & cryptography
Secure communication protocols, certificate management, identity and access protection and threat modeling for exposed components. TLS · PKI/X.509 · OAuth2/OIDC · Keycloak · threat modelingQuality assurance & test automation
QA as an independent service area with dedicated staff: test strategy, test case management, unit, GUI and E2E automation through to the fully automated pipeline. xUnit · Cypress · Selenium · Squish · Testcontainers · ISTQBFrequently asked questions
Do you handle the approval?
No. We deliver development, testing and the associated documentation in the form your quality management needs for approval. The procedure itself is run by your QM officer.
Can you work with DOORS and existing traceability?
Yes, that was the norm in the laser system project — requirements in DOORS, reviews in Fisheye/Crucible, builds via Jenkins.
Contact
Your contact
Software architecture & technical project management