The self-styled low cost surgical camera company Olive Medical Corporation of Salt Lake City, tells us it has achieved ISO 13485:2003 certification for its quality management system (QMS) through certification body BSI
It’s over eighteen months since innovative minimally invasive surgical (MIS) visualization products company Olive Medical gained U.S. FDA 510(k) clearance and announced the worldwide sales launch for the OVS1 All-in-one HD Visualisation system.
Now with ISO 13485:2003 under its belt the company has made another important step in complying with all the performance standards for the manufacture of medical devices. Olive Medical markets the only native True 1080P HD CMOS video system at significant cost reductions from other MIS visualization manufacturers to the operating room and office markets.
It is the stated goal of Olive Medical to be in compliance and manufacture to the highest standards for the benefit of its customers, the company seeing this step as an opportunity to expand its worldwide distribution relationships and to continue to create better products at competitive and affordable prices for all markets.
In case you’re wondering about how a company can get its products to market without such a fundamental standard under its belt, this is because devices can be approved on an individual basis without Quality System underpinnings. The bigger question is quite why a company would choose to tread that path, when gaining ISO13485 certification is such a useful instruction book of guidance on how to run your operation. Anyway, they’ve got it now, so that’s perhaps a moot point.