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Certified Quality

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.

State-of-the-Art Facility

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.

Continuous Improvements

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.

Quality Persists Throughout Our Organization

Our commitment to quality is evident throughout the whole organization.  Our quality commitment to ourselves in all we do and to our customers is experienced from the initial design to the delivery of the final product.

“MediSurge has been a key partner in setting up new processes as well as adopting legacy processes for Surge Cardiovascular.  Their willingness to take on all of challenges associated with medical device manufacturing and to do so with focus on lean manufacturing and cost reduction is a rare commodity.”

Rick Shorey

Surge Cardiovascular

Industry Expertise

Because of our team’s extensive industry experience, we are equipped with the knowledge needed in order to create unique solutions and effective products. We have also built a network of industry partners that will be leveraged in order to positively impact your bottom line.

Passion

At the end of the day, MediSurge exists to better the world of healthcare. We never settle for the status quo and are always looking to leverage the technologies of tomorrow in order to create the highest quality products. Together, with our partners, we are creating the healthcare of the future, today.

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ISO 13485:2016 Certified

 

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