EN 62304 Certification?

Last week, I guided a client and their software developer through a notified body audit. Thankfully, this particular developer was well polished (albeit not ISO 13485:2003 certified) resulting in a smooth and quite impressive audit result. The length of the audit was far shorter than any of us anticipated resulting in some dead time to simply chat.

At one point, the conversation meandered to the type of certification that the developer could pursue to improve their business and, as crass as it sounds, limit the number of notified bodies that bother them. The developer asked if there was an EN 62304 certification available, to which the auditor responded that he was not aware of one. As the conversation progressed, I suggested that it would be akin to the ISO 17025 certification. Test labs offer a testing service and are certified to provide that service in a manner consistent with ISO 17025. Why shouldn't there be a similar program for EN 62304? Software developers offer development services and are expected to comply with EN 62304. A program should be established by which a developer can show evidence that their systems are compliant with EN 62304 and receive a certificate.

Furthermore, an EN 62304 certification program makes far more sense for many of these software developers, especially if they are developing imbedded software. These developers are typically sub-contracted and often work in other industries than just medical devices. An ISO 13485:2003 certification may not make the most sense for the developer, but the EN 62304 certificate would fit perfectly.

The medical device industry should be pushing on organizations (notified bodies, AdvaMed, etc.) with the intent of establishing a certification program to fit better with sub-contracted software developers.

-RTK