FDA / Medical Expertise
Artison has developed, designed and manufactured medical ultrasound devices since 1973. In addition to securing FDA marketing approval for more than 30 of our own products, we have partnered with other companies to assist them in developing portions of their approvals. With our assistance, partners in the European Union and Japan have received regulatory approval for their clinical trials.
We are an FDA-registered facility and have a quality system certified to meet the requirements of ISO 13485:2003 from TUV Rheinland.
Thousands of products are manufactured at our facility each year under the Artison name and other names as an OEM medical device supplier. We pride ourselves in our robust products and full life-cycle support.
If you are interested in discussing your specific project, please email Ken Coffey, President/CEO at firstname.lastname@example.org