Medical Device Recalls from Wiring? Hospital-Grade Cable Assemblies？

Medical Device Recalls from Wiring? Hospital-Grade Cable Assemblies？

Did wiring flaws cause 34% of Class II medical device recalls last year? Prevent  

patient risks with ISO 13485-certified Medical Cable Assembly solutions from our  

FDA-registered facility.  

Life-Critical Specifications:  

• Silicone/PUR jackets (USP Class VI biocompatible)  

| Test                | Standard         | Our Performance     |  

|---------------------|------------------|---------------------|  

| Flex endurance      | IEC 60601-1      | >250,000 cycles     |  

| Ethylene oxide res. | ISO 10993-7      | Zero material decay |  

| EMI shielding       | EN 60601-1-2     | 60dB attenuation    |  

Traceability Protocol:  

Each Medical Cable Assembly includes:  

- UDI-compliant barcode (21 CFR Part 11)  

- Material Certificates (REACH/RoHS)  

- Sterilization compatibility report  

Value-Added Services:  

► Co-design with your engineering team (Free DFM analysis)  

► Rapid prototyping: 72-hour sample turnaround  

► Batch-specific test videos  

Real Impact:  

Swedish dialysis machine manufacturer eliminated field failures after adopting  

our Medical Cable Assembly for blood sensors. "Zero incidents in 18 months vs.  

previous 3% failure rate" - Quality Director