Media/Articles

For this article, MasterControl Inc., a leading software provider for life sciences and other regulated industries, interviews Lori A. Carr, a medical device specialist with the FDA’s Office of Regulatory Affairs (ORA) in the Denver District Office. ORA is the lead office for all of FDA’s field activities. Investigators (also called consumer safety officers) like … Read more

With the unsteady economy and the ever-changing regulatory world that we find ourselves in, strong design controls within the medical device and biotech industries are a necessity. When faced with a multi-million dollar recall, no medical device company wants to wish it had instituted more robust design controls. Therefore, having a solid design control system is a must … Read more