MediSurge is an ISO 13485:2016 certified and FDA Registered medical device contract manufacturer. Our team also holds a Japan Foreign Medical Device Manufacturing certificate. We understand the importance of, and are committed to, introducing safe and high-quality medical devices into the market.
Our revolutionary facility allows us to bring innovative products to life. In addition to our ISO Class 7 Cleanroom, our world-class engineering team has access to a 1,000-square-foot quality lab/wet lab, 3 loading docks, plus an additional 15,000 square feet of white space ready for additional capacity.
We routinely update procedures and processes to ensure we are not only meeting, but exceeding, the ever-changing industry regulations. Medical devices have the ability to save, or positively impact someone’s life, and, because of this, we don’t take our work lightly.