M
MEFRON
Healthcare

Medical Device Harness

Custom cable and wire harness assembly for FDA-grade medical equipment — clean room environment, medical-grade materials, 100% hi-pot tested.

Clean Room Medical Grade Hi-Pot Testing IPC/WHMA-A-620 ISO 13485
12,000+
Units Produced
Zero
Field Failures
ISO Class 7
Clean Room Class
100%
Test Coverage
Medical Device Harness

About the Project

Mefron Technologies partnered with a medical device OEM to manufacture custom cable and wire harnesses for patient-monitoring equipment. The project demanded the highest quality standards — biocompatible materials, clean room assembly, and 100% electrical testing for every unit. Our dedicated clean room (Class 10,000 / ISO 7) ensured zero contamination, while our certified wire harness team followed IPC/WHMA-A-620 standards throughout.

Project Highlights

Medical-grade silicone wiring with biocompatible insulation materials
Assembly performed inside ISO Class 7 (Class 10,000) clean room facility
100% continuity testing, hi-pot (dielectric withstand) testing on every unit
Precision crimping with pull-force tested terminations
UL and IEC 60601 standard adherence for medical electrical equipment
Traceability documentation for each assembly — lot number, operator, test result

Project Outcome

Zero field failures recorded across 12,000 harnesses deployed in hospital environments. Full compliance achieved for ISO 13485 medical quality management system audit.

Services Used

  • Cable & Wire Harness
  • Clean Room Assembly
  • Prototype Assembly

Industry

Healthcare

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