If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
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Showing posts with label hazard analysis. Show all posts
Showing posts with label hazard analysis. Show all posts
Friday, October 30, 2009
Tuesday, March 3, 2009
Hazard Analysis for Medical Devices Under IEC60601 and ISO14971
If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register please visit our site www.fxconferences.com
This audio conference has been pre-approved by RAPS as eligible for one (1)credit toward a participant's RAC recertification upon completion.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register please visit our site www.fxconferences.com
This audio conference has been pre-approved by RAPS as eligible for one (1)credit toward a participant's RAC recertification upon completion.
Labels:
hazard analysis,
IEC60601-1,
ISO14971,
Markus Weber,
risk,
System Safety Inc.
Wednesday, February 11, 2009
A Practical Guide to Hazard Analysis for Medical Devices
If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.
This presentation provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
A Practical Guide to Hazard Analysis for Medical Devices is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com
This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.
This presentation provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
A Practical Guide to Hazard Analysis for Medical Devices is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com
This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.
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