Software Regulated as Medical Devices – Looking at Other Markets, Globally

16 May 2011

Over the last few weeks, this blog has explored several in-depth topics as it relates to medical software regulated as a medical device. In these particular blog entries, different market variables have been explored, from classification to software lifecycle processes, specifically as they relate to the United States, Canada and the European Union. But what about requirements for other markets, globally?

"The latest version of the Medical Device Directive specifically lists software as a medical device depending on its intended use for companies selling in the European Union, but other countries have also established requirements for software," said Christine Forcier, Program Manager for the medical device sector at Intertek. "By helping manufacturers understand various country requirements for software to be regulated as a medical device, manufacturers will be able to market products quicker, ensure compliance and demonstrate that safety standards are met."

In the coming weeks, this blog will explore several other markets across the globe and educate organizations on these various differences – no matter how subtle or how intricate. To learn more and or to speak with an Intertek expert on this subject matter, e-mail us at askmedical@intertek.com.