Architecture
Requirements, risks, and evidence before heavy spend.
Hardware Form / Build / Medical devices
Engagements
Medical device manufacturing under ISO 13485
We run an ISO 13485 quality management system for medical device work: design controls, document control, supplier qualification and traceability by serial number.
We run an ISO 13485 quality management system for medical device work: design controls, document control, supplier qualification and traceability by serial number. Regulatory submissions stay with your team; we provide the manufacturing records they need.
Integrated build
Electronics, mechanics, and firmware on one schedule.
Validation
EVT/DVT with factory-representative units and test scripts.
Manufacturing
SMT, assembly, and NPI on the same lines that validated the design.
Typical engagement — illustrative, not a client case study
A medtech startup has a working handheld monitor and a regulatory consultant. We transfer the design under ISO 13485 document control, qualify suppliers, build fixtures for calibration, and produce DVT units with the device history records their submission needs.
Questions
How do projects start?
Send a brief through Start a build. We review stage, technical risk and manufacturing fit, then propose ODM, JDM, OEM, CM or a recovery path with a scoped first phase.
Who owns the IP?
You own your product IP, design files, firmware and test specs. Ownership is written into the contract before work begins. Under JDM, a subsystem ownership map is agreed at kickoff.
What's the difference between ODM and OEM?
With ODM we do the engineering and the production. With OEM you hand us a released design and we build it to your spec. See partner models for JDM and CM.
What is NPI?
New product introduction: the EVT, DVT and PVT builds, fixtures, test coverage and documentation that turn a working design into something the line can build the same way every time.
Do you work with funded startups?
Yes. Most of our programs start at seed or Series A with a working prototype. We size the first phase to the next milestone you need to hit.
What certifications do you hold?
ISO 9001 and ISO 13485 quality management systems and BSCI social compliance. We have taken client products through UL; listings are product-specific and owned by the client.
Will you sign our NDA?
Yes, before we review detailed files.
Where is production?
Engineering and production are in Shenzhen, China, with design reviews held in your time zone.