What We Build
Integrate the enclosure, approved electronics, harnesses, configuration and verification into a defined finished or partially finished unit — while product-level regulatory compliance stays with the OEM.
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Send your drawing, BOM or idea — we reply with a practical Box Build scope review.
A medical device Box Build usually brings the released enclosure, mounting structure, approved PCBAs, cable assemblies, power and interface components, displays, controls, labels and product-specific verification into one controlled assembly. The OEM owns the product design, intended use, risk decisions, regulatory strategy and acceptance criteria; our role is to integrate the approved inputs, verify the finished unit and deliver it in the agreed condition. This is enclosure and electromechanical assembly, not full-product OEM ownership.
The difficult part is rarely the parts list. It is defining how design intent becomes controlled assembly evidence without confusing a manufacturing record with proof of regulatory compliance. Our Box Build for medical devices framework walks through the boundary, documentation and controlled-environment questions an OEM should settle before an RFQ.
We prepare the approved enclosure and internal mounting structure, then install brackets, standoffs, panels, seals, grounding hardware, gaskets and interface parts. Cutouts, sealing surfaces, connector presentation and cover clearances are checked as part of enclosure integration.
Approved PCBAs, power supplies, batteries, displays, sensors and control devices are installed to the released assembly definition. Mounting, isolation, thermal contact, cleanliness and access are coordinated through PCBA integration and electromechanical assembly.
Harnesses and point-to-point connections follow the approved connection map, with attention to bend radius, separation, strain relief, retention, sharp edges, labels and service loops. Connection and polarity checks are defined with the harness integration scope.
Where required, approved firmware or device parameters are loaded and recorded. Unit device identification, serial identity, labels, warnings, accessories, manuals and protective packaging are applied according to customer-approved files with labeling and serialization before release.
Medical requirements are not inferred from the product category. They must be defined by the drawings, specifications and customer-approved acceptance plan, then assigned in a responsibility matrix so that product-level compliance and assembly verification are never confused.
Product-level medical compliance — including ISO 13485, FDA and IEC 60601 obligations where applicable — remains the OEM's responsibility. We record the assembly and verification evidence agreed for the project; those records support the OEM's device history record but do not independently establish product compliance.
Any controlled-environment, cleanliness or handling requirement should enter the RFQ as a measurable specification with an approval and evidence path. No one should imply cleanroom capability or a particular environmental classification without verified, applicable evidence.
Component identity, lot or serial capture, work-instruction revisions and inspection results are recorded to the agreed plan. The route and depth of records are defined with quality and traceability so the evidence matches what the OEM's documentation actually needs.
A project may require defined power-up behavior, calibration references, indicators, controls, communications or selected I/O checks. The functional-test package must state setup conditions, fixtures, limits, expected responses, pass or fail rules, data capture and the process for failures, rework and retest.
For a new or changed design, an NPI or pilot build can expose access, routing, sequence and test issues before repeat production. Approved findings feed back into the BOM, drawings, work instructions and verification package under change control.
Send the current product definition and mark preliminary information clearly. The most useful package explains both the physical build and the evidence required at handover.
BOM, approved sources, quantities, variants, assembly drawings, enclosure CAD, seal and gasket details and a list of customer-supplied items.
Connection diagrams, PCBA and harness revisions, grounding and isolation requirements, firmware, configuration values and programming access.
Inspection criteria, functional-test procedure, fixtures, acceptance limits, required records, any controlled-environment specification and ownership of product-level certification activities.
Unique device identification and serial rules, label artwork, accessories, manuals, packaging, delivery condition, build quantity, forecast and requested timing.
Use the complete Box Build RFQ checklist or return to all product types.
Have a BOM, assembly drawings, enclosure CAD, harness requirements or test procedure? Send what you have. We’ll confirm the Box Build scope, identify missing information and outline the next step before quotation.
Send your drawing or idea and we’ll reply with a practical Box Build scope review.