The capability extract shows in thirty seconds what runs as standard and what carries a surcharge.
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To the data check →Medical device electronics rarely push the technology further than automotive does. What differs is that the documentation is part of the product: a device file has to show what was built, by which validated process, and what would have happened had anything changed.
Two technical themes recur. Miniaturisation, because a device that goes on or into a body has a volume budget before it has an electrical one — which is why HDI and rigid-flex dominate. And reliability evidence, because a Class 3 acceptance level and documented process capability are what the notified body will want to see, not a statement that the boards work.
The third theme is change control, and it is the one that catches suppliers out. In a medical programme, a change to a laminate, a plant or a process parameter is a regulatory event with a validation cost attached. That means the discipline is not "can you build this" but "can you keep building exactly this, and tell us before anything moves".
Traceability, inspection records and material certification per production lot — assembled as a package rather than reconstructed on request.
HDI and rigid-flex, which is what a volume-constrained device usually needs. Rigid-flex also removes the connectors that fail in a sealed housing.
No silent substitutions. Any change to material, plant or process is notified so you can assess the regulatory impact before it reaches a build.
What accompanies a medical series build. Scope is agreed per programme with your quality function.
| Document | Scope | Availability |
|---|---|---|
| Certificate of conformity | Per lot, against the agreed specification | standard |
| Traceability record | Lot to laminate batch and plant | standard |
| Inspection record | IPC-A-600 Class 3 criteria | standard |
| Microsection report | Barrel quality, plating thickness | per lot on request |
| Impedance report | TDR coupon per panel | where specified |
| Material certification | Laminate and finish | standard |
| Change notification | Material, plant or process | contractual |
| Process validation | Agreed per programme | on request |
Guide values for pre-selection. Binding values are confirmed per project against your data.
The points below are what most often comes back as a query after data review. Settling them before layout freeze saves a loop.
Once a device is validated against a specific board, the stack-up, material and plant are part of the regulatory record. Make that explicit in the specification so nothing is treated as a purchasing variable.
Where the board is near tissue or fluids, finish and mask selection may need biocompatibility evidence. Raise it at enquiry stage — it is not something to discover during device testing.
In a sealed handheld device the connectors are usually the first thing to fail. Replacing board-cable-connector with one rigid-flex part removes the failure mode along with the assembly step.
Reconstructing lot records after the fact is expensive and sometimes impossible. Define what accompanies each delivery before the first series order, not during an audit.
The relevant certification sits with our partner plants, and our processes are built around it. We will tell you exactly which certificate covers which step — vagueness here helps nobody, least of all during an audit.
Yes. Certificate of conformity, traceability, inspection records and material certification as standard, with microsection and impedance reports on request. The package is agreed with your quality function before the first series order.
Any change to material, plant or process is notified before it reaches a build, so you can assess the regulatory impact. That is the whole point — a silent substitution that would be harmless on an industrial board is a validation problem here.
Finish and mask selection can be matched to a biocompatibility requirement, but the evidence usually attaches to the finished device rather than the bare board. Tell us the requirement and we will tell you what we can document.
Send us your data or a rough sketch. We check feasibility, name the cost drivers and answer within one working day.