Medical and Life Sciences

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Medical Device Product Development

Today’s medical and life sciences companies face intense cost pressures to develop new innovative products in shorter time frames while meeting strict regulatory requirements of medical device design. To meet these challenges D&K Engineering brings subject matter expertise, medical device product development services and the requisite process discipline to ensure your products meet regulatory requirements from pre-clinical through product submission and continuing to support post-market surveillance.

Through our Total Commercialization Solutions™ medical device development process with hundreds of product commercialization journeys, you can be sure your product will be designed and manufactured to meet exacting DHF and DMR requirements while meeting your business and market requirements. D&K Engineering is a medical device development & design company with facilities that are ISO 13485 certified and FDA registered.

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
  • 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

Testimonials

“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

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