Cordica Medical
From Concept to Care

Medical devices built for the moment that matters.

From first concept through commercial scale, we partner with medical
device companies to bring their most important innovations to life.

Medical devices built for the moment that matters.
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Built Different

Design. Development.
Manufacturing. One team.

At Cordica Medical, engineering and manufacturing begin simultaneously rather than sequentially. Our highly skilled engineers work closely with manufacturing teams across 19 facilities, ensuring that DFM, regulatory requirements, and production setup are incorporated into your device from the very first design review.

End-To-End Capabilities

One partner. At every step. Fully integrated device solutions.

From product design and development to precision manufacturing, automated assembly, packaging, and supply chain management, we support your entire program with validated production processes in FDA-registered and ISO 13485-certified facilities, delivering consistent quality at every stage and enabling a faster, reliable path from prototype to commercial launch and scale.

Capabilities
Product Design & Development
Rapid Development
Catheter & Shaft Manufacturing
Custom Precision Extrusion
Medical Molding
Medical Converting
Surface Technologies
Machining & Laser Technologies
Medical Textile & Flexible Material Processing
Bristling & Brush Manufacturing
Device Assembly & Kitting
Packaging & Sterilization Support
Supply Chain & Logistics
Automated Production & Quality Systems
Finished Good
Catalyst by Cordica Medical

From concept to FDA submission. With the manufacturing answer already built in.

Catalyst unites device engineers, designers, manufacturing, and regulatory specialists into a single program, so your device is built right from the start and ready for 510(k) or PMA review.

STEP 01.

Clinical Unmet Need Evaluation

Start with the real clinical problem and confirm a clear, viable path to market from day one.

STEP 02.

Integrated Design & Development

Engineering, manufacturing, quality, and regulatory work in parallel to build for speed and scale from the start.

STEP 03.

Rapid Prototyping & Architecture

Turn the concept into a working prototype and a scalable architecture, built to reach your next milestone sooner.

STEP 04.

Pilot Manufacturing & Validation

Prove equipment, processes, and parameters on a pilot line that mirrors the future commercialized solution.

STEP 05.

Regulatory & Submission

Run fully validated processes with automation and in-line quality control for consistent, cost-efficient volume, through launch and beyond.

STEP 06.

Scaled Production, Launch & Post-Market

Run fully validated processes with automation and in-line quality control for consistent, cost-efficient volume, through launch and beyond.

Markets

Where complexity meets scalability across the full therapeutic spectrum.

Every therapeutic market has its own regulatory, performance, and manufacturing requirements. Cordica Medical is built to meet them across the spectrum, from complex interventional systems to drug delivery, wound care, and personal health solutions.

Automation & Scale

Automation engineered around your device.

Cordica Medical operates 19 facilities across the United States, Mexico, and Singapore, featuring dedicated automation systems, validated processes, and cleanroom environments across the platform. With ISO 13485 certification and FDA registration at applicable facilities, your program benefits from a compliance infrastructure that scales with your needs. From design to prototyping to subassemblies and fully finished devices, your program can seamlessly move from prototype to commercial volume within the same manufacturing infrastructure, eliminating handoffs and transfer risks that can slow down progress.

  • Validated automated processes, to support commercial scale
  • In-line quality control, built into every run
  • Prototype to commercial, all under one roof
Automation facility
Insights & News

Insights from people building tomorrow’s advanced devices.

Engineering perspectives, technical guidance, industry intelligence, and company news from the Cordica Medical Team.

Ready to bring your next device to life?

Ready to bring your next device to life?

Tell us about your program or device needs. Our engineering team is ready to help bring your project closer to production.

Contact Us Today
Cordica Medical

Cordica Medical is the development and manufacturing partner for leading OEMs innovating the most demanding medical devices. We bring engineering, manufacturing, and regulatory together so complex devices move smoothly from first concept through FDA submission and commercial scale. Headquartered in Knoxville, TN, with 19 facilities across the United States, Mexico, and Singapore, we serve the full therapeutic spectrum, from interventional systems to drug delivery, wound care, and personal health.