The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.
Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.
This audio conference examines how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.
IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices was presented on 2007-02-15 and is available for download at www.fxconferences.com
Showing posts with label Underwriters Laboratories. Show all posts
Showing posts with label Underwriters Laboratories. Show all posts
Thursday, March 5, 2009
Wednesday, November 19, 2008
Global Unifying Trends in Device Regulation
Device manufacturers who want to reach world markets are faced with a plethora of regulatory schemes that appear to be disjointed and unconnected.
Although, at first glance, this may be true, there are some harmonizing influences afoot that wise manufacturers can take advantage of in marketing their products across the globe. The audio conference with explore these possibilities.
Global Unifying Trends in Device Regulation was presented by Harvey Rudolph, PhD, Global Program Manager, of Underwriters Laboratories on 2005-04-13. For more details on this audio conference, or to purchase a download, please visit our site www.fxconferences.com
Although, at first glance, this may be true, there are some harmonizing influences afoot that wise manufacturers can take advantage of in marketing their products across the globe. The audio conference with explore these possibilities.
Global Unifying Trends in Device Regulation was presented by Harvey Rudolph, PhD, Global Program Manager, of Underwriters Laboratories on 2005-04-13. For more details on this audio conference, or to purchase a download, please visit our site www.fxconferences.com
Monday, July 21, 2008
IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices
The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.
Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.
This audio conference will examine how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.
This event is presented by Harvey Rudolph of Underwriters Laboratories. To learn more, please visit www.fxconferences.com.
Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.
This audio conference will examine how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.
This event is presented by Harvey Rudolph of Underwriters Laboratories. To learn more, please visit www.fxconferences.com.
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