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Medical Device Manufacturing Capabilities Services
With nine medical device facilities totaling nearly 400,000 sq. ft. of engineering, and production capabilities, including ISO 14644-1 Class 7 and Class 8 certified clean rooms, Cirtec can meet your needs, from pilot/clinical builds to full scale production. Our systems are ISO 13485:2016 or ISO 9001:2015 certified to ensure consistent quality management for your finished devices and components.
- Identify potential technical and manufacturability issues before they disrupt production or inflate your budget
- Achieve your cost of goods targets
- Save you money and resources by managing your supply chain
- Enable small and complex devices to be safely and precisely implanted
- Scale on demand – from batch production builds to high volume finished goods
- Eliminate or avoid fixed operational costs
Your Full-Service Outsource Partner
We can design, develop and manufacture all components, controls and electrical and mechanical functions in your product, as well as assemble them into a finished device for testing, validation, and final production. Our industry-leading core competencies include:
- Catheter delivery systems
- Application Specific Integrated Circuits (ASICs)
- Thin-film and flexible circuits
- Leads design and manufacturing
- Nitinol tubing
- Machining and Swiss turning
- Wire EDM
- Precision metal stamping
- Coil winding
- Hermetic welding and testing
- Laser welding and cutting
- Silicone molding
- In-house EO sterilization
Other capabilities include:
- Laser marking
- Resistance welding
- Electronic assembly
- Ultrasonic welding and resistance welding
- Epoxy molding and backfilling
- Die bonding
- Surface treatment
- Laser ablation
- Catheter assembly
- Ultrasonic welding
- Packaging and labeling
- Cleanroom assembly
Medical Device Component Manufacturing Capabilities:
- Medical machining, multi-axis Swiss machining, 5-axis machining centers, micromachining
- Precision stamped components, micro components
- (Multi-access) Component Grinding
- Precious metal manufacturing
- High velocity machining
- Laser welding, tube cutting, marking, assembly
- Wire coiling and wire forming
- Plasma & resistance welding
- Catheter tipping
- Silicone & thermoplastic insert molding
- Nitinol components and processing