Transforming a new concept into a market-ready medical device is no simple task. At Smithwise, we partner with innovators to transform their early concepts into robust designs and manufactured products. Our team of engineers, designers and industry specialists work to develop, prototype and manufacture medical devices, while reducing technical, regulatory and market risks along the way. Our ISO 13485 process ensures that you will reach FDA and other agency submissions with the proper documentation and our robust supply chain enables you to launch quickly, scale-up efficiently, and keep fixed costs low.
As a provider partner with the Boston Pediatric Device Strategic Challenge, Smithwise will be providing development and prototyping support to the challenge awardee(s).