Engineered Success: The Engineer’s Contributions to FDA Medical Device Commercialization
The contributions engineers make to this industry are both critical and substantial. Medical devices must be designed to satisfy their intended use. Some medical devices are simple enough – or the appropriate tools are sufficiently accessible to non-engineers – that a professional engineer may not be necessary for their design. However, a medical device always requires some level of engineering, and the bulk of medical devices require the skills of a professional engineer to ensure they safely and effectively fulfill their approved intended use.
In this white paper, we outline an FDA regulatory pathway a medical device might follow on its road to commercialization in the United States… but with a slightly different twist. In this paper you will learn about:
- The role engineers play in the commercialization process
- Getting a practical handle on 21 CFR Part 820
- Implementing design controls
Thinking of the commercialization strategy from concept through completion will enable you to develop processes that will bring your product to market faster, easier and quite possibly more affordably… allowing you to move on to your next brilliant idea! So, if you’re looking to be competitive in a global marketplace… this article is a must read!