Medical Software Standard IEC 62304 Ready for World Stage
May 17, 2012 – 8:20 amThe ratification and update of IEC 62304, a standard for the design of medical products recently endorsed by both the European Union and the United States, has prompted medtech developers to wonder if IEC 62304 might not have the outlines of a global medical device standard. A universal development process that ensures the safety and quality of medical devices is needed, write LDRA’s Anil Kumar, a technical consultant based in India, and Mark Pitchford, Field Applications Engineer, in an article published on medicalelectronicsdesign.com.
IEC 62304 can be the foundation of such a process, they add in “Easing IEC 62304 Certification for Medical Devices.” They also look at how to bring legacy products into compliance in the article.
The first part of this two-part article is now available on the MED website.

MD&M, the world’s leading medical manufacturing event, is coming to India for the first time in May. Taking place in Mumbai from 23 to 25 May 2012, 
