A 2-day workshop hosted by America’s Blood Centers will review current requirements for medical device data systems (MDDS). Reclassified as Class I devices by FDA in 2011, the systems transfer, store, convert, or display medical device data. Though reclassified 2 years ago, the impact is just beginning to be felt in blood centers, hospitals and other areas where medical devices are used.
Scheduled for January 15-16, 2014, in Silver Spring, Md, the workshop will look at MDDS requirements from a range of perspectives, including those of the FDA, device manufacturers, and hospitals. It will review the impact of the requirements on healthcare institutions and offer insights into complying with them. Participants will learn what an MDDS is, what regulatory requirements apply, and how to navigate FDA device inspections and development in a quality systems environment.
For more information, visit the ABC website.
