YC Cable Taiwan — ISO 13485:2016 Certified

Medical-Grade Cable & Wire Harness Manufacturing — Taiwan

ISO 13485:2016 Certified
Built to your drawings and BOMs. Full traceability. Cleanroom-ready processes.

YC Cable Taiwan has achieved ISO 13485:2016 certification for medical device cable and wire harness manufacturing.

• We do not design cables.

• We manufacture strictly to customer-provided designs and BOMs.

• We source all components and propose alternates if requested.

• We provide validated production with comprehensive quality records.

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Certification Scope

• Manufacture of medical device cables and wire harnesses

• Procurement and incoming inspection per BOM

• In-process and final inspection with documented traceability

• Cleanliness controls; ESD and labeling per customer requirements

What You Get

• Lot-level traceability (materials, processes, operators, equipment)

• Document control & change management aligned with ISO 13485

• Validated processes and inspection records for every shipment

• Turnkey sourcing with vetted suppliers (Molex, TE, JST, etc.)

Capabilities

• Micro-coax & fine gauge assemblies

• Overmolding

• Ultrasonic welding

• Soldering (IPC-A-610/WHMA-A-620 standards)

• Labeling & serialization

• Electrical testing

• Functional testing (per customer specifications)

Industries Served

• Medical: patient monitoring, diagnostic imaging, surgical, lab/IVD

• Life Sciences: genomics, bioprocess, analytics, research instrumentation

• Consumer/Industrial: when medical-grade process control or documentation is required

Quality & Compliance

• ISO 13485:2016 certified Quality Management System

• RoHS/REACH compliant materials upon request

• Device history records (DHR) and certificates of conformance (CoC)

• First Article (FA) inspection: internal by default; customer FA available upon request