Industry
Medical & Life Sciences
We support medical device companies from early feasibility through design verification. Our work is documented the way your quality system expects (design inputs, traceable requirements and verification evidence), so nothing has to be reconstructed later.
What makes it hard
The problems we solve most often
- 01Design-control documentation aligned with ISO 13485 and 21 CFR 820
- 02Usability engineering and formative studies (IEC 62366)
- 03Biocompatible material selection and cleaning validation
- 04Low-noise analog front ends for sensing and diagnostics
Product types we build
Services involved
Case study
A point-of-care reader, from napkin to clinic in 14 weeks
A handheld fluorescence reader for lateral-flow assays, built in 40 units for a formative usability study across three clinical sites.
Working in medical & life sciences?
We can share more detailed examples under NDA, including documentation samples and test reports from comparable programs.
Talk to an engineer →Next step
Tell us what you’re building.
Share as much or as little as you can. A senior engineer reads every inquiry and replies within one business day, usually with a few sharp questions and a suggested first step.