We are committed to providing the highest quality devices to our customer's satisfaction, while maintaining compliance with all applicable global and regulatory requirements.

ISO 13485:2016

Our Quality Management System is certified to ISO 13485:2016. We believe in the standard's strict design controls and requirements of good manufacturing and documentation practices.

The foundation of our culture at Midwest Interventional Systems is each team member's ownership of, and commitment to the quality of the devices we design and manufacture. Quality is at the core of our business model and paramount to the success of our services and partnerships. Quality is the foundation on which our company stands.

Click Here to download our ISO 13485:2016 Certification.

FDA Registration #3016842760

Class 7 Cleanroom

Our cleanroom is ISO 14644-1:2015 Class 7 certified to provide the proper controlled environment for packaging of finished devices. Manufacturing and assembly of components and devices also takes place in the Class 7 environment, where appropriate. Our cleanroom is monitored and maintained per ISO 14644-2:2015.

‍"Quality tends to fan out like waves. The Quality job he didn't think anyone was going to see is seen, and the person who sees it feels a little better because of it, and is likely to pass that feeling on to others, and in that way the Quality tends to keep on going."
‍-Robert M. Pirsig, Zen and the Art of Motorcycle Maintenance (1974)