VITAL STATISTICS
Year Founded: 1987
Number of Employees: 1,600+
OUR FACILITIES:
- Brooklyn Park, MN 1 – Corporate Headquarters
- Brooklyn Park, MN (BP2) – Neuromodulation Center of Excellence
- Brooklyn Park, MN (NovelCath) – Interventional Center of Excellence
- Los Gatos, CA – Design Center
- San Jose, CA - NovelCath (fka Cardea Catheter Innovations)
- Santa Clara, CA – West Coast Center of Excellence for Catheters and Delivery Systems
- Chandler, AZ
- Lowell, MA
- Sturtevant, WI – LSR Molding/Extrusion Center of Excellence
- Sturtevant, WI – Engineering Center
- Rock Hill, SC – HCR Molding Center of Excellence
- Birkenfeld, Germany – Vascotube – Precision Implantable Tubing
- Birkenfeld, Germany - Cirtec Medical Services GmbH
- Coyol Free Zone, Costa Rica
QUALITY
- All sites use or integrate into Cirtec’s Corporate Quality Management System
- All Sites ISO 13485:2016 certified
- Six Sites FDA Registered – Brooklyn Park 1 & 2, Costa Rica, Enfield, Los Gatos, NovelCath 2
- Providing Quality System support for:
- CE Mark
- 510K
- PMA applications
ABOUT US
Your fully-integrated, full-service outsourcing partner for complex medical devices for over 30 years, Cirtec provides end-to-end product design, development and manufacturing of Class II and III medical devices and components. We specialize in today's most advanced product technologies including:
WORLD CLASS CAPABILITIES IN THREE DIVISIONS
- Interventional
- Design and development services
- Finished device assembly
- Precision machined & stamped components
- Coil winding
- Laser welding
- Nitinol tubing/processing
- Neuromodulation / Active Implants
- Design and development services
- Software, firmware, hardware
- Implantable Pulse Generators (IPG)
- ASIC design
- VAD
- Thin-flex circuits
- Leads, Cables, Connectors
- Patient controllers
- Precision machined & stamped components
- Precision Components & Devices
- Application Specific Integrated Circuits (ASICs)
- Thin-film and flexible circuits
- Nitinol tubing
- Machining and Swiss turning
- Wire EDM
- Precision metal stamping
- Coil winding
- Hermetic welding and testing
- Laser marking, welding and cutting
- Silicone molding (HCR & LSR) and extrusion
- In-house EO sterilization
DESIGN & DEVELOPMENT
- Flexible and robust design control system
- High concentration of engineers – 16%
- Mechanical design
- Electrical design
- Altium design software test system development
- FDA compliant software design controls
- FDA compliant human factors design controls
- Packaging design
- Rapid prototyping
- 3D printing
- In-house machining
- Engineering lab space
- Design verification, process validation, and risk management activities