ECM serves as a long-term manufacturing and engineering partner to a global top 10 medical device company, supporting its infusion and cabling product lines with audit-ready quality systems and bonded warehousing. Industry: Medical Devices.
The Challenge
- Complex global supply chain
- FDA-level quality and change control requirements
- An 18-month production halt
- Regulatory and supply risk
The Solution
- Audit-ready quality systems
- Direct engineering collaboration
- Controlled, traceable change management
- Rapid, compliant production ramp-up
- Bonded warehouse logistics support
The Result
- Production exceeded historical volumes
- Maintained full FDA compliance
- Eliminated backlog
- Enabled 18-month forecast capacity planning
- Expanded into additional programs
Ongoing Value Delivered
Direct engineering collaboration ensures design changes are implemented with full traceability, approvals, and manufacturability alignment. California-based bonded warehousing supports the customer’s global logistics strategy, avoiding import tariffs while preserving U.S. supply chain flexibility. 18-month rolling forecasts enable proactive capacity planning and risk mitigation for high-volume programs.
Contact Us Today
Need a manufacturing partner who can meet FDA-level quality standards at scale? Contact ECM.