Contract design & manufacturing · Therapy and recovery devices
Your device. Designed, cleared and built by one team.
We take traction, compression, massage and thermal therapy devices from first sketch to production, ready for the US, EU and Australian markets.
- US FDA 510(k)
- EU MDR 2017/745
- AU TGA · ARTG
Certified to the standards your buyers check first
ISO 13485:2016MDSAPFDA Registered FacilityQMSR · 21 CFR 820EU MDRTGAIEC 60601-1
Device expertise
Five device families. Nothing else.
Focus means our test plans, suppliers and production lines are already proven on devices like yours.
Engineering under one roof
Every discipline your device needs
One partner, start to finish
From concept to shipped units
- ConceptNeeds, feasibility and regulatory pathway
- DesignMechanical, electronics, firmware, pneumatics
- TestIEC 60601, usability, biocompatibility
- Submit510(k), MDR technical file, TGA
- BuildPilot runs to volume production
Built for confident decisions
See how quality is built in →A clear path through a complex device launch
You do not need vague promises. You need visibility into what is being decided, why it matters and what comes next.
Decisions at the right time
Review scope, risk, evidence and cost before each major commitment.
One connected development loop
Engineering, regulatory and manufacturing choices stay aligned from prototype to production.
Documentation that moves with the product
Design history, test evidence and production knowledge are organized for the next stage—not left behind at handoff.
Have a device idea, or a design that needs a new manufacturer?
Tell us your stage. We reply within 2 business days and sign an NDA before any technical discussion.