Sep 14, 2011

Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?

That was one issue addressed during the FDA’s quality management systems in order to satisfy FDA requirements.

But app developers targeting the US medical device market had better prepare for just such a requirement, according to AdvaMed director of technology and regulatory affairs Bernie Liebler. “What do you have in place to guarantee software quality?” he argued. “It’s very difficult—even after validation, software can be buggy.”

Liebler suggested that requiring software developers to have quality systems in place or abide by some kind of recognized standard would not be unreasonable, echoing the FDA’s guidance recommending that “all manufacturers of all mobile apps that may meet the definition of a device follow the Quality Systems regulations (which include good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.”

Just such an approach was taken by MedApps, a remote health monitoring technology developer. MedApps CEO Kent Dicks explained that his firm undertook quality system implementations not only to meet potential regulatory requirements but also (and just as importantly) to attract investors.

Going forward, medical app developers aligning their products more closely with medical devices had best get used to the idea of quality system implementation, both to satisfy regulators and effectively raise capital.


  • Stewart Eisenhart