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IPC/WHMA-A-620 Class 3 cable assemblies and wiring harnesses engineered for patient-connected devices, diagnostics equipment, and surgical systems.
Key engineering and supply chain challenges in this sector — and why specialist knowledge matters.
Patient safety demands IPC Class 3 workmanship — the highest standard for cable assemblies. Every solder joint, crimp, and termination must be inspectable and traceable.
MHRA, FDA, and EU MDR require full material traceability. Every component — wire, connector, heat-shrink — must be traceable to batch and lot number.
Patient-contact assemblies require materials that withstand autoclave sterilisation and meet ISO 10993 biocompatibility requirements.
Medical devices remain in service for 10–15 years. Component obsolescence management and second-source qualification are critical to long-term supply.
Purpose-built solutions from Circuit Source for this sector.
All medical assemblies are manufactured to IPC/WHMA-A-620 Class 3 — the highest workmanship standard. Every assembly undergoes 100% visual inspection and electrical testing.
Complete material traceability from raw cable to finished assembly, with Certificates of Conformance, test reports, and First Article Inspection Reports (FAIRs) as standard.
ECG leads, patient monitoring cables, ultrasound probe connections, and surgical instrument wiring — manufactured with medical-grade silicone, TPU, and biocompatible materials.
Internal wiring for imaging systems, blood analysers, ventilators, and laboratory instruments. Complex multi-connector looms with EMC shielding for sensitive analogue signals.
7-day UK rapid builds aligned to your regulatory submission timeline. We produce design-verification and design-validation units to the same Class 3 standard as production.
We proactively monitor component lifecycles and provide last-time-buy alerts and pre-qualified second sources to protect your supply chain over the full product lifecycle.
Relevant approvals and quality standards for this sector.
Core capabilities that support this sector.
From rapid 7-day UK builds to cost-effective Far East volume production — engineered to IPC/WHMA-A-620 Class 2 & 3.
View serviceCircuit Source is a trusted custom power supply manufacturer with over 20 years of experience designing and supplying high-quality AC-DC power solutions.
View serviceEnd-to-end management from concept to sea-freight volume — we handle sourcing, manufacturing, logistics, and quality control.
View serviceOur UK facility operates to IPC/WHMA-A-620 Class 3, and our manufacturing partners hold ISO 13485 certification for medical device component production. We provide full documentation packages including Certificates of Conformance, FAIRs, and material traceability records to support your quality management system.
Yes. Our 7-day UK rapid build service produces design-verification and design-validation units to the same Class 3 standard as production assemblies. We also provide the documentation — dimensional reports, test data, material certificates — that regulatory bodies expect.
We regularly use medical-grade silicone, TPU, and PTFE cables, along with stainless steel and gold-plated connectors suitable for autoclave sterilisation. Material selection is driven by your ISO 10993 requirements and the intended patient-contact classification.
We proactively monitor component lifecycles through our supply chain partners and provide advance notification of end-of-life and last-time-buy dates. For critical components, we pre-qualify second sources and maintain a list of approved alternatives so your production isn't interrupted.
All medical assemblies receive 100% automated continuity testing (Cirris), hipot/dielectric withstand testing where specified, pull-force testing on crimps and terminations, and a full visual inspection to IPC Class 3 criteria. We provide complete test documentation with every shipment.
IPC Class 3 quality, full traceability, and UK rapid prototyping — get a quote from our specialist team. No minimum order quantity.
Get a Medical Assembly Quote