Currently browsing "Life Sciences"
-
Theranos – A Case Study on Risk and Reputation Management
Until recently, no one could get enough of Theranos and the company’s founder, Elizabeth Holmes – the exceptionally young, self-made billionaire whose fortune has been made on a single sought after medical technology: an easier, faster and less invasive way to carry out blood tests. Indeed, Holmes, still in her early thirties, has been widely […]
-
Facing an FDA audit in the medical device manufacturing industry
If you are a medical device manufacturer, you already understand the substantial role regulations and regulatory agencies play in your business. In particular, the FDA’s 21 CFR Part 11 standard. The FDA audit is one of the most anxiety-producing prospects for medical device manufacturers, and for many manufacturers, it is also the most challenging part […]
