Ensuring Quality in the Medical Device Industry

Warehouse shelves with boxes on them and the phrase, "Safety and quality are paramount in the medical device industry, and there is no room for error."

 

Choosing a medical device company can be a daunting task, it is key to partner with a team who places quality above all else, ensuring the success of your product. At MediSurge, we understand the importance of introducing safe, easy-to-use, high-quality medical devices into the market that will ultimately improve patient care and outcomes.

Our experienced team’s commitment to quality is unmatched, and we are constantly improving systems and processes in order to maintain exemplary results throughout every step of our process, we accomplish this through:

Industry certifications

Safety and quality are paramount in the medical device industry, and there is no room for error. Because of this, there are strict industry regulations and requirements throughout every step of a product’s life cycle.

MediSurge is an ISO 13485: 2016 Certified Contract Manufacturer, meaning our processes meet the internationally-agreed-upon standard for the medical device industry. We routinely update procedures and processes to ensure we are not only meeting, but exceeding, the latest industry regulations.

Additionally, MediSurge is FDA Registered, which is required for all domestic manufacturers, and is one of the first things you should look for when seeking a medical device partner. Our team also holds a Japan Foreign Medical Device Manufacturer certificate.

Class 7 Cleanroom

Under ISO regulations, cleanrooms are classified according to the cleanliness level of the air inside them. MediSurge is proud to have a 1,000-sqaure-foot Class 7 Cleanroom on site that is managed with extremely stringent regulations. Our team prides ourselves on maintaining a low particulate count and strong environmental controls. Our cleanroom allows us to provide the best possible products to our customers.

State-of-the-art facility

Our revolutionary facility allows us to bring products to life through innovative design control processes. In addition to our Class 7 Cleanroom, our world-class engineering team has access to a 1,000-square-foot quality lab/wet lab, plus an additional 15,000 square feet of white space ready for additional capacity.

At the end of the day, MediSurge exists to better the world of healthcare, and that requires a steadfast focus on quality. Medical devices have the ability to save lives, and, because of this, our products are designed to be the best, every time, with no exceptions.

 

To learn more about our capabilities, or to connect with a member of our awesome team, reach out to us today.

 

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