is being presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants and airs on Thursday, March 3rd, 2011. For more details or to register, please visit our site at www.fxconferences.com
Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS). These two collateral standards are an extension of IEC 60601-1:2005, the general standard. Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.
In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.
Ease your development stress for HHE and EMS devices with detailed guidance from a leading expert!
Showing posts with label IEC60601-1. Show all posts
Showing posts with label IEC60601-1. Show all posts
Thursday, February 3, 2011
Tuesday, July 14, 2009
How to Mark & Label Devices Under IEC60601-1 3rd Edition
Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices.
Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too!
In this audio seminar, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from version two you need to know for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.
How to Mark & Label Devices Under IEC60601-1 3rd Edition was presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and aired on 2007-10-23. For more details or to download this conference, please visit our site at www.fxconferences.com
Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too!
In this audio seminar, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from version two you need to know for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.
How to Mark & Label Devices Under IEC60601-1 3rd Edition was presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and aired on 2007-10-23. For more details or to download this conference, please visit our site at www.fxconferences.com
Tuesday, March 17, 2009
IEC 60601 3rd Edition: Overview and Adoption Update
The IEC 60601 3rd Edition represents a major change in the way medical devices are evaluated and approved. This audio conference will provide an overview of the major differences between the 2nd and 3rd Editions of the standard, including process changes for assessing acceptable risk, in addition to the electrical and mechanical changes.
Because the changes have a major impact on the way certification is viewed, there is still a lot of discussion among the major medical markets on how to interpret the standard, what national differences to include, and what requirements will be required to assess conformity. We also provide an update on the adoption status in the major medical device markets.
IEC 60601 3rd Edition: Overview and Adoption Update aired on 2007-09-13 and is available for download at www.fxconferences.com
Because the changes have a major impact on the way certification is viewed, there is still a lot of discussion among the major medical markets on how to interpret the standard, what national differences to include, and what requirements will be required to assess conformity. We also provide an update on the adoption status in the major medical device markets.
IEC 60601 3rd Edition: Overview and Adoption Update aired on 2007-09-13 and is available for download at www.fxconferences.com
Thursday, March 5, 2009
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
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
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.
Thursday, January 22, 2009
Industry Update: Where Do We Stand With IEC 60601-1 3rd Edition?
IEC 60601-1 is the cornerstone standard for medical electrical devices, yet development and adoption of the latest edition has been a long, complicated process. Three years after publication, there is still mass confusion over the ever-changing international and regulatory requirements impacted by the 3rd edition of IEC 60601-1. What is the best strategy for your company when it comes to designing your product to IEC 60601-1? Should you design to 2nd or 3rd edition, or both? The answer depends on where and when you will be selling your product!
In this audio conference, Leo Eisner provides a status update on IEC 60601-1 3rd edition, and discusses planned revisions, important regulatory dates related to the standard, and how the collateral and particular standards are aligned to 3rd edition. There are major changes from the 2nd edition, changes you need to know about in order to comply. Get the answers to your 60601-1 compliance questions from a leading expert!
Industry Update: Where Do We Stand With IEC 60601-1 3rd Edition? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Tuesday, February 10th, 2009. For more details or to register for this conference, please visit our site at 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.
In this audio conference, Leo Eisner provides a status update on IEC 60601-1 3rd edition, and discusses planned revisions, important regulatory dates related to the standard, and how the collateral and particular standards are aligned to 3rd edition. There are major changes from the 2nd edition, changes you need to know about in order to comply. Get the answers to your 60601-1 compliance questions from a leading expert!
Industry Update: Where Do We Stand With IEC 60601-1 3rd Edition? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Tuesday, February 10th, 2009. For more details or to register for this conference, please visit our site at 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.
Tuesday, November 18, 2008
How to Mark & Label Devices Under IEC60601-1 3rd Edition
Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices.
Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too!
In this audio seminar, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from version two you need to know for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.
How to Mark & Label Devices Under IEC60601-1 3rd Edition was presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants on 2007-10-23. By popular demand, we are re-broadcasting this audio conference on Tuesday, December 2nd, 2008. For more details or to register, please visit our site www.fxconferences.com
Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too!
In this audio seminar, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from version two you need to know for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.
How to Mark & Label Devices Under IEC60601-1 3rd Edition was presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants on 2007-10-23. By popular demand, we are re-broadcasting this audio conference on Tuesday, December 2nd, 2008. For more details or to register, 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.
Friday, July 18, 2008
How to Mark & Label Devices Under IEC60601-1 3rd Edition
One of the key items that need to be resolved before a project can go through a complete translation for a medical device is to know the marking and labeling requirements of the devices, the user manuals, the screen prompts, and the packaging. One key aspect of marking and labeling requirements comes from IEC 60601-1, the standard for medical electrical devices. IEC 60601-1 has gone through a major paradigm change in the way medical electrical devices are evaluated.
Along with the change in paradigm are some new and modified requirements and test methods for the marking and labeling of these devices. This audio conference will highlight changes to marking and labeling requirements from the second to the third edition.
How to Mark & Label Devices Under IEC60601-1 3rd Edition is presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants. For more details on this audio conference, please visit our site www.fxconferences.com
Along with the change in paradigm are some new and modified requirements and test methods for the marking and labeling of these devices. This audio conference will highlight changes to marking and labeling requirements from the second to the third edition.
How to Mark & Label Devices Under IEC60601-1 3rd Edition is presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants. For more details on this audio conference, please visit our site www.fxconferences.com
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