A Practical Approach to Medical Device Risk Management

is being presented by Harvey Rudolph, Ph.D., HRRM, LLC, Risk Management Consultant and airs on Tuesday, August 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com

Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.

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 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

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

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.