We have become increasingly interconnected, and so have our devices. Some sources state that in as little as six years, there may be as many as 26 billion devices on the Internet of Things. With this much growth comes a great deal of risk, particularly when the devices going "online" are associated with patient care. Sensitive information in the wrong hands could...

In manufacturing, design issues are expected to some degree, but when it's medical devices being produced as opposed to televisions, for instance, the stakes are much higher when something goes wrong. Naturally, the FDA keeps a close eye on medical device manufacturers, but these organizations can beat them to the punch with a strong CAPA system in place.

Innovation is the name of the game at Apple, and the tech giant may be breaking into the medical device manufacturing sector with the introduction of the iWatch. Pending FDA approval, of course. But is the company ready for the move into such a highly regulated environment, where the product will be under constant scrutiny?

Recent legislation has had a significant impact on the trade of conflict minerals, including "blood diamonds," out of areas ravaged by war and run by warlords. The deadline for reporting supply chain partners, per Dodd-Frank, has come and gone, and companies have found it difficult to say with certainty whether their materials are truly conflict-free. A QMS can be hugely helpful here.