Medical Device Development
Everything you need for your healthcare and medical device development
From concept through manufacturing and FDA approval, we’ve got you covered
Medical device development and the FDA certification process requires high standards of testing, process and documentation that often goes above and beyond the needs of standard product development.
Kickr’s medical device team and on-staff biomedical engineers can help you navigate the unique challenges of medical device development, documentation, prototyping and production.
Our turn-key medical development services include design control, risk management, and prototyping through contract manufacturing.
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
- Feasibility studies
- 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
- Design Controls and Quality Assurance Processes, ISO 13485
- Documentation for FDA approval, 510(k) submission support and certification for Class I through Class III devices
Smart Syringe
This conceptual medical device helped doctors provide more accurate dosing for patients, ultimately saving time and preventing potential errors or oversights.
Kickr Design developed the internal electronics, user interface (UI) and external housing. We then built the prototype for user testing.
Medical Innovations we’ve been part of
Let’s bring your project to life!
Interested in developing or getting FDA approval of a medical device?
Our team of engineers is here to help. We offer free consultations and estimates.
Fill out the form for your free cost estimate.
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