/ Medical Devices
Medical Devices
510(k) / MDR
ISO 13485. The 510(k) and MDR gate is structured and ready for commercial engagement.
YOUR ARTIFACT · UNDER THE GATE
GATE CHECKS · 510(k) DHF package
Structural factor of safety ≥ 1.50
Tip deflection ≤ 1.0 mm at rated payload/reach
Minimum wall thickness ≥ 2.0 mm
Internal tool clearance ≥ 3.0 mm
Unit-cost index ≤ 1.40 (nominal = 1.0)
IDU housing wall ≥ 2.0 mm for autoclave sterilisation
Where the part lives or dies.
For Class III devices, the Design History File is the submission. Every verification record, validation protocol, biocompatibility study, and risk analysis must cohere before regulatory review begins. The gate does not forgive gaps.
WHAT THE GATE RECOVERS
60 to 300 hrs
Labour a single submission consumes. About half recovered per verified package.
Toward 95%
First-pass approval rate. Production agents score the full package before it leaves your desk.
Weeks back
Per submission, recovered from review loops and re-test cycles avoided.
1 to millions
Each verified submission authorizes the parts that follow.
Registered
Roadmap
Use cases this sector displaces.
- Assembling the Design History File from distributed verification and validation records
- Cross-validating verification and validation outputs against design requirements
- Carrying biocompatibility and risk evidence in one traceable package
- Flagging DHF gaps before regulatory submission
START HERE
Bring one part. We run it through the gate.
Declare your part and its submission intent. We run it through the Submission Gate and hand back the verdict and the certificate. One part. One pass. Everything cited.
Today we assemble your DHF. Tomorrow we design what it covers.