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Medical Device Design & Product Development Services – D&K Engineering, Inc

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General Medical Device Design Services

  • Medical Device Design and Development Planning per ISO 13485 and 21CFR820
  • Risk Management per ISO 14971
  • Mixing, Vortexing, and Centrifuges
  • Robotics and Precision Placement
  • Inventory and Thermal Management
  • Micro and Macro Fluidic Systems
  • Vision/Lighting Systems and Image Processing
  • Image Processing and Machine Learning
  • System Architecture Design
  • Optical System Design
  • Electronic System Design
  • Firmware and Software Design per IEC 62304
  • Environmental Management & Thermal Cycling
  • Electrical Safety testing per IEC 60601 Standards
  • Consumable Design and Automated Manufacturing and Workflows
  • Component Procurement
  • Managed Inventory
  • Assembly & Testing
  • Rapid Prototyping
  • Supply Chain Management
  • FDA Documentation
  • Develop UI


“D&K Engineering had the depth and breadth to take a product and work closely with our marketing team to take it from a concept to a commercially available product in a very quick fashion. D&K Engineers are a top medical device design company top in their field. They grasped concepts very quickly and not only did they grasp our concepts, they also had the knowledge to add some of their own experiences to make our product that much better. Not only did the product meet our requirements, we also leap-frogged the industry.”

Todd Cushman, Chief Commercial Officer, Bioness

medical device design services

Medical Device Development Applications

  • Medical Devices
  • Automated Clinical Laboratory Instruments
  • Diagnostic Devices
  • Sample Preparation
  • Consumables
  • Assembly Automation
  • Biological Storage
  • Class I & II Devices, Instruments & Consumables
medical device product development services

Technical Capabilities

  • Mechanical Systems
  • Electronic Systems
  • Software
  • Firmware
  • Systems Engineering
  • Computer Vision Systems
  • Optical Systems
  • Control Systems
  • Microfluidics
  • Robotics
  • Thermal Management
  • Mechatronics
  • GUI Software
  • IoMT (Internet of Medical Things)
  • Finite Element Analysis
  • Neural Networks Classification
  • PC, Mobile Devices, Embedded platforms
  • User Interface Design