Medical Device Manufacturing Services

FDA-Compliant Design, Pilot Builds and Volume Production

Cogmedix will help you bring your complex electromechanical medical device from concept to production keeping speed, cost, and compliance at the forefront.

DFcx™

Cogmedix utilizes a unique market approach to medical device development called Design for Compliance and eXcellence™ (DFcx™)

Design for: EN60601-1, EN60601-1-2, EN60601-2-22
Design Control compliant to: 21CFR820.30, ISO13485, ISO14971, IEC62304

Why Cogmedix?

Our dedicated and passionate team provides expertise in optical, electrical, software, mechanical, and robotic medical device development. We develop meaningful partnerships that drive new medical technologies and accelerate time to market.

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ACCELERATED DEVELOPMENT

Proprietary phase gate process to compliantly bring products to market – starting by capturing product requirements

SCALABLE MANUFACTURING

State of the art FDA-compliant manufacturing space and a world class global supply chain for initial preproduction builds through scaled volume production

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LIFE CYCLE ENGINEERING

Support for supply chain challenges, component and material end of life, and part shortages

cogmedix medical device engineering stage gate process

What can Cogmedix do for You?

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- Product Development
- Engineering Prototype
- Pilot Production
- New Product Introduction
- Volume Manufacturing
- After Market Service and Repair
- Other
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Medical Devices from Concept to Commercialization

Design for Compliance and Excellence™ guarantees quality throughout the product and process

World class global supply chain for initial preproduction builds

Scaled volume production in an FDA-compliant state of the art manufacturing space

Capabilities

Mechanical

Design for Manufacturing, prototype design and evaluations, sheet metal, system structure/frame, and console designs

Opto-Mechanical

Optical system and electro-optical designs with optical alignment/layout, detector system, and laser couplings

Electrical

Embedded microcontroller and Single Board Computer (SBC) Design, Micro and Macro Level System Controllers, Board and System Level Test, Debugging, and Veriﬁcation

Compliance

Sterile packaging, biocompatability, blister pack, and pouches

Thermal

Component and System Thermal Management

Laser

Laser Optical Systems and Fiber Optics Coupling

Software

Real-Time Operating System (RTOS) and Baremetal Implementations, Application Process Control, Graphical and Interactive User Interfaces, Remote Accessibility

Contact Cogmedix