The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD: 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.
It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.
Software as a Device: What You Need to Know About the New MDD was presented by Eric Henning, Senior Project Manager, with KEMA. To purchase a download of this event or for more details, please visit our site at www.fxconferences.com
Showing posts with label KEMA. Show all posts
Showing posts with label KEMA. Show all posts
Tuesday, March 24, 2009
Wednesday, July 30, 2008
Software as a Device: What You Need to Know About the New MDD
The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD: 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.
It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.
Software as a Device: What You Need to Know About the New MDD is presented by Eric Henning, Sr. Project Manager, of KEMA. For more details on this audio conference, please visit our site www.fxconferences.com
It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.
Software as a Device: What You Need to Know About the New MDD is presented by Eric Henning, Sr. Project Manager, of KEMA. For more details on this audio conference, please visit our site www.fxconferences.com
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