is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, January 12th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The revised MEDDEV 2.12-1 Rev 6 guidance about medical device vigilance came into effect in December of 2009. While not legally binding, this guidance does reflect EU competent authority expectations and companies are advised to build their vigilance system around the guidance.
In this audio conference our speaker reviews the guidance, explains key definitions and responsibilities, provides a vigilance process map, and discusses the criteria for reporting using several examples. For instance, a patient with worsening osteoporosis presents with severe ankle pain twelve months after surgical fixation of the ankle with bone graft and hardware (screws and plate). There is movement at the joint, demonstrating lack of fusion. Is this a reportable event?
Finally the presentation looks at event trending and how to use the information that is delivered via the vigilance system.
