Medical Device Manufacturing Services
FDA-Compliant Design, Pilot Builds and Volume Production Contact CogmedixDFcx™
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.
ACCELERATED DEVELOPMENT
SCALABLE MANUFACTURING
LIFE CYCLE ENGINEERING
What can Cogmedix do for You?
Medical Devices from Concept to Commercialization
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