Services
Medical Device R&D
From requirements analysis to a verified prototype, a development process aligned with design controls that produces traceable documentation.
Medical device development demands evidence beyond a good idea: every design decision must trace to a requirement, and every requirement to a test. Our R&D service builds that chain from day one, so decisions made at prototype stage do not have to be reconstructed later for technical documentation.
Work starts with a short requirements workshop. We define user needs, the use environment and the regulatory framework together, then compare alternative concepts for feasibility and risk. The chosen concept becomes a prototype through two-week iterations; each iteration ends with a tested, visible build.
At handover you receive more than a working prototype: the documents that explain it. Design inputs, the risk analysis file, test reports and the traceability matrix are ready for the next steps.
What we do
- Definition of user needs and design inputs
- Concept design and feasibility study
- Coordination of electronics, embedded software and mechanical design
- Prototyping and design verification tests
- Verification and validation (V&V) plan and reports
- Technical documentation and design history file support
Process
-
Requirements workshop
Use scenarios, user profiles and the regulatory framework are clarified together.
1 week -
Concept and architecture
Alternative concepts, preliminary risk assessment and architecture decisions.
2–3 weeks -
Prototype iterations
Two-week cycles; each cycle ends with a tested build.
Project dependent -
V&V and handover
Test reports, traceability matrix and technical documentation inputs.
2–4 weeks
What you receive
- Design inputs document
- Risk analysis file
- Working prototype and test reports
- Traceability matrix
Frequently asked questions
Do you develop both hardware and software?
Can we start from an existing prototype?
How is intellectual property handled?
Not sure which service fits?
Let us clarify it together in a short discovery call. Free and non-binding.