Medical Device Design Services
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. As a leading medical device engineering company and to meet these challenges, D&K Engineering brings full-service contract manufacturing, subject matter expertise, medical device product development services, and the requisite process discipline to ensure your medical device design meets
regulatory requirements from pre-clinical through product submission and continuing to support post-market surveillance.
Why work with D&K Engineering’s Medical Device Design Services & Product Development Team?
Through our Total Commercialization Solutions™ medical device product development services with hundreds of product commercialization journeys, you can be sure your product (device, equipment, or machinery) will be designed and manufactured to meet exacting DHF and DMR requirements while meeting your business and market requirements. D&K Engineering, a medical device engineering company, is a medical device product development company with facilities that are
ISO 13485 certified and FDA registered. To learn more about our medical device design company
contact us today.
| Certifications & Quality | ||
|---|---|---|
| FDA Registered Facility | ISO 13485:2016 | Class I & II Devices |
See our approach to Total Commercialization Solutions®
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
Bioness Case Study
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
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
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
White Papers
Medical Device Portfolio
DNA Sequencing Machine
Lens Fluorescence Biomicroscope
HIV Diagnostic System
Ophthalmic Surgical Equipment
Fitness Machine for the 50+ Age Market
DNA Sequencing Consumables
Rehabilitation Device
Automated Sample Preparation Instrument