Xeridiem designs, develops, and manufactures complex single use medical devices for urology, cardiology, and gastroenterology. For over 25 years, Xeridiem had enabled major companies and venture-backed entrepreneurs to launch over 200 medical devices that have become standards of care. Your Vision. Designed. Delivered.
Xeridiem orchestrates design and development of medical devices with an emphasis on design for manufacturability and including regulatory submissions in the US and the EU. Our services help clients bridge the gap between concept and commercialization. Whether you are an established medical device company or an medical device entrepreneur just getting started, we offer a full menu of design development and manufacturing services designed to simplify your life and launch your device quickly an cost effectively. We have a track record of on-time, on-budget project completion; no surprises.
Our goal is to be the trusted & acknowledged worldwide leader in the OEM design, development and launching of single use minimally invasive medical devices.
Xeridiem Medical Devices, winner of MD+DI ‘s 2011 Medical Design Excellence Award in General Surgery Equipment, Instruments and Supplies, is a designer and developer of complex, single use, minimally invasive, medical devices .
For 23 years, Xeridiem has enabled major companies and venture-backed entrepreneurs to launch over 200 medical devices that have become standards of care worldwide. We have more than 25 years experience with silicone in medical manufacturing and we created the first temperature sensing catheter, including the first silicone catheter to treat benign prostatic hyperplasia.
We have helped our clients file more than 90 510ks with the FDA for over 1,000 different medical products. Xeridiem-developed medical devices have been used in more than 22 million patients worldwide.
We are certified to or comply with the following:
- ISO 13485:2003, Medical Devices – Quality management systems – Requirements for regulatory purposes
- Code of Federal Regulations (CFR) 21 Part 820, as amended, The Quality System Regulation for Medical Devices (QSR), 07 OCT 1996
- Canadian Medical Device Regulation (CMDR), SOR98/282
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD), as amended
- ISO 14971:2007, Medical Devices – Application of Risk Management to Medical Devices
Xeridiem, founded as MRI 25 years ago is backed by the technical and financial strength of our multinational parent company, Fenner plc. Xeridiem is ISO 13485:2003-certified and FDA-registered and is located in Tucson, Arizona.
