We have a working Class IIa infusion set accessory that has passed internal bench testing. We are preparing for EU MDR technical documentation review by our notified body and our design controls are incomplete.
We need a compliant design history file and risk management file built around the device we already have, structured so our notified body can assess it without a string of deficiency letters.
| File | Type | Size | Access |
|---|---|---|---|
| Current device documentation set | ZIP | 120 MB | NDA required |
| Bench test data | XLSX | 16 MB | NDA required |
| eQMS templates | DOCX | 9 MB | NDA required |
| Device CAD & drawings | STEP | 34 MB | NDA required |
A milestone is accepted and paid when these are demonstrably met — not when it is merely submitted.
Submitted proposals are normalised into the same axes so they can actually be compared. The platform does not choose for the client — it makes the technical comparison transparent.
Lowest price is not automatically ranked first. Price sits alongside methodology, assumptions, verification and availability, because the cheapest proposal against an incomplete methodology is not the cheapest project.
Each match shows the evidence behind the score — and states what is missing rather than hiding it behind a rank.
We need a compliant design history file and risk management file built around the device we already have, structured so our notified body can assess it without a string of deficiency letters.
We need a compliant design history file and risk management file built around the device we already have, structured so our notified body can assess it without a string of deficiency letters.
We need a compliant design history file and risk management file built around the device we already have, structured so our notified body can assess it without a string of deficiency letters.
We need production-intent schematic and layout with a fabrication package that passes DFM at our assembly house first time, and an antenna layout that actually achieves range.
