Medical device innovation and development Services
Kickr Design offers everything you need for your healthcare and medical device development. Our turn-key medical development services include design control, risk management, and prototyping all the way through contract manufacturing. Kickr's engineering team provides all of the services to expertly design, test, and manufacture your Class I and Class II medical devices. We are certified to ISO 13485:2003 for design and can assist you in all aspects of the FDA regulatory filing process. Throughout the development process, we work directly with you to realize every important aspect of your device, including:
- Determining the technical specifications of your device
- Engineering & design for usability
- Selecting and optimizing the appropriate materials
- Building, integrating, and testing software solutions
- Prototyping and testing your design
- Packaging design including labeling requirements
- Writing documentation and filing all appropriate paperwork for FDA approval and certification for Class I and Class II devices
For this project, we were asked to develop hardware, software, and electronics for a completely portable X-ray imaging system for operating rooms. Kickr has supported Micro-C from concept all the way through research, design, prototyping, FDA approval, and manufacturing. Learn more about Micro-C Imaging
Our clients at FIGARO CROWNS™ INC are the inventors of the patent pending fiberglass crowns known for being the strongest, prettiest, and best value for any dental restorative. Kickr Design has supported FIGARO CROWNS™ with materials formulation, design, prototyping, testing, Canada Health, FDA & CE approval and manufacturing.
Interested in developing or getting FDA approval of a medical device? Have any questions about our services? Contact us to get in touch with one of our expert engineers!