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Quality Development and Design

MediSurge is an ISO 13485: 2016 certified and FDA Registered custom medical device contract manufacturer. We specialize in the design, development, and manufacturing of sterile and non-sterile medical devices. We constantly improve our systems and processes to ensure we are staying ahead of ever-changing regulations.

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 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

With our industry expertise, if you have a concept we can partner together to bring your concept to life from design to launch at a cost that makes sense.

Certified Quality

We are ISO 13485:2016 certified and through a combined focus on creating quality products as efficiently as possible and a strict adherence to a quality management system, we are able to pass cost-saving value onto our customers.

PRODUCT

At MediSurge, we are committed to providing our customers with the highest quality products along with customizing services to meet the needs of our customer.  

FACILITY

Our state of the art facility includes a 2,000 square foot facility, 3 Loading docks, a ISO Class 7 Clean room, a 1,000 sq. ft. quality lab/wet lab, plus an additional 15,000 square feet of white space ready for additional capacity.

CERTIFIED

We are ISO 13485: 2016 certified, an FDA registered company and also hold a Japan  Foreign Medical Device Manufacturer certificate.