We enhance your medical device development with comprehensive value-added services, from rapid prototyping to complex assemblies. Our experienced team understands the demands of medical innovation, providing efficient solutions to accelerate your path to market.
Need Things Fast
Accelerate your medical device development with our extensive inventory and rapid production capabilities.
In-Stock Components:
- Mandrels, polyimide, extrusions
- PET HS, FEP HS, balloons
Raw Materials for Quick Custom Components:
- Coils, tubes, wire, beading
- Braided/coiled shafts
- Pull ring assemblies
- Endoscope coil pipes
Rapid Production Methods:
- Plastic casting and molding
- Machining
- 3D printing (metal and plastic)
Our diverse inventory and versatile manufacturing enable us to meet tight deadlines without compromising quality.
From off-the-shelf components to custom solutions, we’re equipped to support your urgent needs.
Facing a time crunch? Let’s discuss how we can expedite your project and keep your development on track.
Sub Assembly
Streamline your medical device production with our comprehensive sub-assembly services.
From wire components to complex endoscope parts, we add value at every step.
Key Capabilities:
- Laser Welding and Cutting (Femtosecond Lasers)
- EPTFE Stent Attachment
- Pull Ring Assembly
- Endoscope Sub Assembly
Benefits:
- Simplified production process
- Reduced incoming inspections
- Time and cost savings
Our expert team collaborates closely with you, leveraging cutting-edge techniques to create precision sub-assemblies.
Whether simple or sophisticated, we optimize your supply chain and accelerate device development.
Ready to enhance your manufacturing efficiency? Let’s discuss how our sub-assembly expertise can elevate your medical device production.
Catheter Manufacturing and Design Services
Innovative catheter solutions through our Co-Lab with MIS. Specializing in balloon, multi-lumen, steerable, and reinforced shaft catheters.
Key Advantages:
- Industry expert engineers with decades of experience
- Rapid access to on-hand materials
- Cost-effective, customizable MIS Handle system
Co-Lab Highlights:
- Iterations in as little as 1 week
- Average program cost: $5-25K
- Hands-on collaboration with frequent updates
Our responsive team delivers swift prototyping, cost-effective solutions, and a transparent development process.
From concept to production, we accelerate your catheter innovation without compromising quality.
Ready to revolutionize your catheter design? Book your 1-on-1 consultation today and leverage our expertise to bring your vision to life.
Catheter Assembly and Testing
Comprehensive catheter manufacturing and validation services in our state-of-the-art facility.ss how our assembly and testing capabilities can bring your innovation to market.
In-House Capabilities:
- Braiding and coiling
- Balloon bonding
- Tipping & Flaring
- Reflow & Lamination
- Laser Welding & Bonding
Testing Suite:
- ISO 10555-1,4 catheter testing
- Surface and tensile testing
- Flow rate and power injection
- Balloon fatigue, burst, and compliance
- Dimensional and distal tip analysis
Quality Assurance:
- ISO 13485 certified
- Process validation
- Lot traceability
From rapid prototyping to full-scale production, our experienced team ensures your catheter meets the highest quality standards.
We offer validated in-house testing methods to streamline your development process.
Ready to accelerate your catheter project? Let’s discuss how our assembly and testing capabilities can bring your innovation to market.
Laser Cut Design, Stents, FEA
Comprehensive design and testing services for medical devices, specializing in Nitinol implants and delivery systems.
Capabilities:
- Concept-to-reality development
- Nitinol device optimization using FEA
- Rapid iteration prototyping
- Material and implant testing
Testing Services:
- Af testing of Nitinol, tensile testing
- Pulsatile durability, bending durability
- Comprehensive ISO 25539 testing suite
Key Advantages:
- In-house design and manufacturing
- Decades of Nitinol design experience
- Rapid concept proving and finalization
Our engineers tackle challenges at any development stage, offering a unique blend of design expertise and manufacturing capability.
From cardiovascular to neurovascular implants, we provide the services you need to bring your device to market.
Ready to optimize your design or validate your implant? Let’s discuss how we can accelerate your innovation.
Catheter Development, PDP, Commercial Manufacturing
Accelerate your catheter project through our robust 5-phase Design Control process, from concept to commercialization.
Our Approach:
- FDA Design Control Guidance and ISO 13485 compliant
- Flexible partnership at any stage of development
- Comprehensive design history file creation and management
5-Phase Process:
- Concept Development: Define initial design inputs and user needs.
- Feasibility: Develop product design and manufacturability processes.
- Design Verification: Conduct testing to validate design outputs meet inputs.
- Process Validation: Establish consistent manufacturing processes.
- Commercialization: Scale-up production and implement process controls.
Key Benefits:
- Rapid progression to next development phase
- Tailored support for your project’s current stage
- Seamless transition from design to manufacturing
Our experienced team guides you through each phase, ensuring regulatory compliance and efficient product development.
Whether you’re at concept stage or ready for scale-up, we’re committed to advancing your catheter project.
Ready to move your catheter innovation forward? Let’s discuss how we can accelerate your project to its next crucial phase.
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