Video Clip - Reclassifying MDDS From Class III to Class I: Impact On MDDS Manufacturers

Reclassifying MDDS From Class III to Class I: Impact On MDDS Manufacturers

On February 15th, 2011, the US FDA reclassified Medical Device Data Systems, or MDDS, from Class III to Class I with sweeping effects on MDDS manufacturers. This year, manufacturers must have quality management processes in place that are compliant with the more stringent requirements for Class I devices as defined in 21 CFR, Part 820. Find out what this means for you.

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