FDA’s Promises for 2014
Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly.
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.
It’s a Small World After All
At GBMP’s recent Northeast Shingo Prize Conference in Hyannis, Massachusetts, the Center for Comparative Medicine (CCM) displayed adaptations of lean to biomedical research in its Community of Lean Lounge.
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.