FDA-Compliant Cable Assembly: 100% First-Pass
How we helped a Fortune 500 medical device company pass FDA inspection on the first attempt while achieving 45% cost savings and zero quality escapes.
Client
Fortune 500 Medical Device Company
US-based surgical equipment manufacturer
Industry
Medical Devices
Surgical & patient monitoring
Products
Cable Assemblies
Patient-contact cables
The Challenge
A leading US medical device manufacturer was at risk of missing critical product launches. Their previous Asian cable assembly supplier had failed an FDA audit, forcing them to find a new qualified supplier capable of meeting strict ISO 13485 requirements with complete lot traceability.
Key Pain Points:
- 1Previous supplier failed FDA audit with 5 major findings
- 2Missing lot traceability for regulatory compliance
- 3Product launches at risk due to supply uncertainty
- 4No cleanroom manufacturing capability at current supplier
Requirements:
- ISO 13485:2016 certified production
- Complete lot-level traceability
- Biocompatible materials (patient contact)
- Cleanroom assembly environment
Our Solution
We implemented a comprehensive quality management system specifically designed for medical device manufacturing, ensuring every aspect met FDA expectations.
Dedicated Cleanroom Production Cell
We established a dedicated Class 100,000 cleanroom production cell exclusively for medical device assemblies. Climate-controlled environment with HEPA filtration, gowning protocols, and particle monitoring ensures contamination-free production.
Complete Documentation System
Full Device History Records (DHR) with lot-level traceability from raw materials to finished goods. Every wire, connector, and component tracked through barcode scanning with real-time quality data capture.
Mock FDA Audit Preparation
Our quality team conducted comprehensive mock FDA audits before the actual inspection. We addressed potential findings proactively, trained operators on documentation requirements, and ensured every process was audit-ready.
Biocompatible Materials Certification
All patient-contact materials certified to ISO 10993 biocompatibility standards. Material certificates, lot traceability, and supplier qualification documentation maintained for every component.
The Results
"The FDA inspector was impressed with the documentation system. In 15 years of medical device manufacturing, I've never seen a supplier pass on the first attempt with zero findings. Their quality team's preparation and attention to detail exceeded our expectations.
Compliance & Certifications
ISO 13485:2016
Medical devices quality management system certified
FDA Registered
Facility registered with FDA for medical device manufacturing
ISO 10993
Biocompatibility certified materials for patient contact
Technical Specifications
| Production Environment | Class 100,000 Cleanroom |
| Materials | ISO 10993 biocompatible certified |
| Traceability | Full lot-level with barcode tracking |
| Documentation | Complete DHR (Device History Records) |
| Testing | 100% electrical, visual, and dimensional inspection |
| Certifications | ISO 13485, FDA Registered, UL Listed |
Need FDA-Compliant Cable Assemblies?
Get ISO 13485 certified production with complete traceability. Our quality team ensures your products meet regulatory requirements.