Device Evaluation according to FDA standards
The design, development and testing of innovative health care products and processes occurs outside of the clinical setting, and often in workshops or laboratories. Our expertise and experience are completely aligned with helping medical device companies meet FDA requirements and establish valid and effective training.
Simulation technologies can be used as a tool to catalyze health care innovation, to:
- Discover areas of need with regard to medical innovation (needs analysis)
- Define the focus of a medical innovation solution to a clinical problem
- Develop design solutions that can benefit from iterative testing in an authentic clinical environment, with real end-product users
- Deliver working prototypes that have been tested in realistic clinical settings
This process can enable a ‘fail early, fail often’ approach to health care innovation.