Full-Spectrum Manufacturing

Complex devices. Complete capabilities.

From product design, development, and regulatory support through precision manufacturing, automated assembly, verification and validation, packaging, and supply chain management, our capabilities span a broad range of medical device markets including minimally invasive devices, gastrointestinal applications, advanced wound care, diagnostics, drug delivery, and personal health.

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Facilities Across 2 Continents

100+

Dedicated Engineers

1M+ sq ft

Global Manufacturing Footprint

FDA Registered Establishments

Design & Development

Built into every device from day one

Cordica Medical's integrated design and development practices cover the full device journey from clinical concept through regulatory clearance, including our Catalyst D&D program, custom extrusion and catheter engineering, micro-molding, specialty performance materials, drug delivery product development, and custom automation design. Manufacturability embedded from day one.

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ISO 13485-Certified

Advanced Manufacturing

Product Design & Development

From clinical concept through regulatory clearance. Design and manufacturing work as one.

Clinical concept translation and device requirements
Catheter, shaft, and materials engineering
Extrusion, molding, braiding, electrospinning, 3D printing, converting, and assembly
Drug delivery and combination product development
Design V&V protocols integrated from concept
Biocompatibility planning
Human factors and simulated use testing
FDA regulatory submission and filing support
Custom automation design
Manufacturability designed in, not retrofitted

Rapid Prototyping

Our R&D engineers move quickly from concept to working prototype across the full range of device types and manufacturing platforms.

Catheter and shaft prototype builds, compliant and non-compliant balloons
Micro-molding for precision miniaturized components
Braiding, coiling, and extrusion
Largest stock catheter tubing inventory available
Electrospinning for advanced material structures
3D printing including biocompatible materials
Converting, lamination, and die cutting
Molding across injection, insert, and overmolding
Medical textile and flexible material builds
Drug delivery device and combination products

Catheter & Shaft Manufacturing

Complex catheter and shaft systems, from prototype to full-scale production.

Multi-lumen extrusion, braiding, coiling, and variable pitch braiding
PTFE liner integration and radiopaque marking
Compliant and non-compliant balloon catheters, ChronoBond™ tie-layer construction
Micro-molding, overmolding, tip forming, and secondary operations
Laser welding, bonding, and shaft pad printing
In-house hydrophilic coating
SLIX® inherently lubricious materials
Sensor and electronics integration
ISO Class 7 and Class 8 cleanroom manufacturing
Steerable sheaths and deflectable catheter systems

Custom Precision Extrusion

Precision extrusion for minimally invasive and implantable device applications.

PEBAX, nylon, polyurethane, fluoropolymers, PEEK, and SLIX® blends
PTFE paste extrusion, ePTFE, etched PTFE liners, and FEP heat shrink
Custom radiopaque compounds and polymer blends
Multi-lumen, bump tubing, balloon tubing, and tapered configurations
Co-extrusion and ChronoBond™ tie-layer for dissimilar material bonding
Chronoprene® compliant balloon tubing
Continuous in-process dimensional monitoring
Prototype tubing available in under five days
Stock tubing and braided stock tubing

Machining & Laser Technologies

Precision CNC machining, Swiss-turning, and femtosecond laser processing for metal and polymer components.

CNC machining, Swiss-turning for precision metal and polymer components
Femtosecond laser cutting, welding, ablation, and micromachining
Nitinol processing with minimal heat-affected zone
Hypotube processing and laser drilling to 0.020"
Burr-free edges and consistent mechanical properties

Medical Molding

From complex geometries to high-volume production. One molding partner for critical care, drug delivery, and personal health programs.

Injection, insert, multi-shot, and overmolding
Amorphous and crystalline engineering plastics
Parts from 0.25g to 2,400g, prototype to high-volume production
40+ molding presses, horizontal and vertical configurations
On-site tooling shop. mold flow analysis, short-run prototype tooling
ISO Class 8 cleanroom manufacturing
Robotics-assisted hands-free production
Pharmaceutical delivery component molding, 21 CFR 820 compliant

Medical Converting

Complex multi-layer converting for wound care, diagnostics, drug delivery, and wearables. ISO 13485-certified environments.

Rotary, matched-metal, steel rule, digital die cutting
Precision stamping, narrow feature cutting to 0.020"
Microfluidic channels in adhesive films
Inline and multi-web laminating with island placement
CGM substrates, cover tapes, wearable patches
Lateral flow, IVD, diagnostic converting
RF welding, ultrasonic welding, heat sealing
Advanced wound dressings, NPWT, hydrocolloids

Medical Textile & Flexible Material Processing

Scale, speed, and supply continuity for wound care, compression, and patient care OEMs. 800+ skilled sewing professionals and 300+ dedicated stations.

RF welding, spot welds to large-format 55x65" platen
Tube mandrel welds, hook/loop, and tears
Single and double needle sewing, lightweight to heavy-duty
Zig-zag, overlock/flatlock, cover stitching, embroidery
Ultrasonic and thermal welding
Dielectric polymer films: PVC, TPU, EVA, composites
Heat sealing, heat staking, and medical pouching
DVT, compression, wound care, surgical draping, isolation gowns

Component to Device

Production & Assembly

Automated Production & Quality Systems

State-of-the-art production systems combined with custom-designed, in-house built automation and test equipment for each device program.

Robotic assembly cells with in-line vision, AI inspection systems
Custom fatigue, tensile, torque, leak, flow/pressure test rigs
In-house test equipment justified, validated for FDA testing
High-speed automated production for select programs
High-volume packaging automation

Device Assembly & Kitting

From sub-assembly to fully finished, tested, packaged device. One accountable manufacturing partner.

ISO Class 7 & 8 cleanroom assembly environments
Manual, semi-automated, fully automated assembly configurations
Catheter, microcatheter, micro-assembly, precision assembly
Ultrasonic bonding, UV-cured adhesive, validated joining methods
Sensor and electronics integration for smart, connected devices
Medical kitting, multiple-piece part assembly, RFID-capable configurations

Surface Technologies

Surface treatments applied in-house with proprietary automated equipment. No outsourcing, no added lead time.

Hydrophilic coatings for catheter and guidewire lubricity
Passivation and electropolishing for corrosion resistance
Plasma discharge, corona treatment, chemical etching for polymer bonding
Etched PTFE liners for composite tubing and deflectable catheters
Custom tube forming: bends, coils, curves for kink resistance and device assembly

Supply Chain & Logistics

One Partner, End-to-End

Integrated planning, global distribution, and inventory management across U.S. onshore, Mexico nearshore, and Asia-Pacific operations. One accountable partner for your entire supply chain.

Vendor-managed inventory, demand forecasting, and S&OP integration

Dual-source supply strategies for continuity and risk mitigation

U.S.-first manufacturing; sourcing across the Americas and Asia-Pacific

Global distribution with direct ship-to-customer capability

Supply chain consolidation; one partner for your finished device

Exclusive Technologies

Performance engineered into the material.

From standard medical-grade thermoplastics to lubricious polymers and bonding systems developed in our facilities, Cordica processes one of the broadest material portfolios in medical device contract manufacturing.

polymers

SLIX® Inherently Lubricious Polymers

Up to 50% friction reduction compounded directly into the polymer matrix. No coating, no delamination risk, no particulates.

PebaSLIX®: PEBAX-based; catheter shafts, delivery systems, steerable sheaths
PolySLIX®: polyurethane-based; balloon catheters, drainage, chronic implant applications
NyloSLIX®: nylon-based; high-torque guide catheters and braided shaft applications
USP Class VI biocompatible; durometers from 75A to 75D
Available as stock tubing for same-week prototyping

bonding adhesives

ChronoBond™ and Chronoprene®

Purpose-built catheter assembly materials engineered as an integrated system for bonding dissimilar polymers that standard medical adhesives cannot reliably join.

ChronoBond™ tie-layer for compliant balloon catheter construction
Bonds PEBAX, nylon, and polyurethane shafts to Chronoprene or Polyblend balloons
Chronoprene® thermoplastic elastomer; silicone-like compliance, thermoplastic processability
Maintains bond integrity through sterilization cycles and mechanical demands
Stock tubing ships within 24 hours; custom within 48 hours

complete system

Vergo® Steerable Sheath

A steerable introducer sheath developed and manufactured by Cordica Medical. Demonstrating the full materials ecosystem from clinical concept through regulatory clearance.

Integrated pull-wire steering for controlled distal tip deflection
Kink-resistant braided shaft for atraumatic navigation
Customizable OEM platform for electrophysiology and structural heart access
End-to-end design, materials, and manufacturing integration

custom applications

Stock Tubing & Braided Stock Tubing

One of the largest stock catheter tubing inventories in the industry. Available for immediate prototyping and development use.

PEBAX, nylon, polyurethane, FEP, PTFE, SLIX®, and other materials
Braided stock tubing in multiple configurations
No minimum order quantities for prototyping
Full engineering application support

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Quality & Compliance

Validated processes. Regulatory-ready infrastructure.

Every capability operates under certified quality systems covering the full scope of medical device design, manufacturing, and packaging.

FDA Registered

Design, manufacturing, and distribution of medical devices

ISO 13485:2016

Design, manufacturing, and packaging of medical devices

ISO Class 7 and 8

Cleanroom manufacturing environments

ISO 9001

Manufacture of components and non-medical products

21 CFR Part 820

Quality System Regulation for medical devices

21 CFR 210-211

Pharmaceutical packaging compliance

MDSAP

Where applicable across the platform

Validation and sterilization Validation

Testing and validation. Programs on schedule.

Validation delays often cause medical devices to miss launch timelines. We incorporate verification, process validation, and sterilization validation at every development stage.

Design V&V protocols integrated from day one; not retrofitted at submission
IQ/OQ/PQ process validation locking manufacturing consistency before scale-up
End-to-end sterilization validation; bioburden, dose setting, dose mapping, and SAL
Biocompatibility planning and test method development per ISO 10993
Accelerated aging and package integrity testing for shelf-life validation

State-of-the-Art Facilities

19 facilities. 10 locations. 2 Continents.

Cordica Medical's manufacturing footprint spans the United States, Mexico, and Singapore, with capabilities distributed across locations to support domestic manufacturing requirements, nearshore cost efficiency, and Asia-Pacific distribution needs.

Headquarter

Knoxville, TN

Facilities

Morristown, TN

Facilities

Haverhill, MA

Facility

Morgan Hill, CA

Facility

Sunrise, FL

Facility

Chino, CA