Is Your Medical Device ‘State of the Art?’
Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.
Recipe for Success: Food Safety Regulations and the Role of Quality Management
Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.
What Kind of Fish Is That?
Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium price?
FDA’s Voluntary Compliance Improvement Program Receives Tepid Response
It’s a growing trend in these United States: paying extra for conveniences such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine, pay-for express lanes.
The Beginning of the End for Fake ISO 13485 Certificates
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent.
