Medical Device Engineering Services

FDA-Compliant Design and Development
Contact Cogmedix
Intertek ISO 13485 Certification
CE European Union Compliance
Intertek ISO 13485 Certification
Intertek ISO 13485 Certification
Intertek ISO 13485 Certification

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


Cogmedix utilizes a unique market approach to medical device engineering 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 Engineering?

Our dedicated and passionate team of engineers provides expertise in optical, electrical, software, mechanical, and robotics engineering. We develop meaningful partnerships that drive new medical technologies and accelerate time to market.

Product Development

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


Accelerated Prototyping, Engineering and Pilot Builds

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

Sustaining 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?

Design for Compliance and Excellence™ (DFcx™)

Design for Compliance and Excellence™ guarantees quality throughout the product and process to ensure best in class products

Risk Management Process (RMP), Risk Hazard Analysis (RHA) and Design Failure Mode and Effect Analysis (DFMEA) to ensure safety


Design Control with Phase Gate approach to ensure efficiency

Engineering Capabilities

Mechanical Engineering

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

Opto-Mechanical Engineering

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

Electrical Engineering

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

Compliance Engineering

Sterile packaging, biocompatability, blister pack, and pouches

Thermal Engineering

Component and System Thermal Management

Laser Engineering

Laser Optical Systems and Fiber Optics Coupling

Software Engineering

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