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 Leo Eisner. Show all posts
Showing posts with label Leo Eisner. Show all posts
Thursday, February 3, 2011
Friday, February 12, 2010
Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?
is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Thursday, March 4, 2010. For more details or to register, please visit our site at www.fxconferences.com
Development and adoption of the IEC 60601-1 standard has been a long and complicated process. Four years after the standard was published, there remains much confusion. This audio conference takes a look at 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 and test to 2nd or 3rd edition, or both? That depends on when and where you plan to market your medical electrical product, whether you will be selling legacy products, and if there are significant changes expected in the future that may require retesting or resubmission to a national regulatory authority.
In this audio conference, 60601 expert Leo Eisner discusses the current status of IEC 60601-1 3rd edition, scheduled changes and important regulatory dates, and how the collateral and particular standards are aligned to 3rd edition. The presentation also covers points to consider when setting up a company transition strategy.
The third edition of this cornerstone standard for medical electrical devices has gone through major changes since 2nd edition. Ease your 60601-1 regulatory compliance strategy stress with detailed guidance from a leading expert.
Development and adoption of the IEC 60601-1 standard has been a long and complicated process. Four years after the standard was published, there remains much confusion. This audio conference takes a look at 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 and test to 2nd or 3rd edition, or both? That depends on when and where you plan to market your medical electrical product, whether you will be selling legacy products, and if there are significant changes expected in the future that may require retesting or resubmission to a national regulatory authority.
In this audio conference, 60601 expert Leo Eisner discusses the current status of IEC 60601-1 3rd edition, scheduled changes and important regulatory dates, and how the collateral and particular standards are aligned to 3rd edition. The presentation also covers points to consider when setting up a company transition strategy.
The third edition of this cornerstone standard for medical electrical devices has gone through major changes since 2nd edition. Ease your 60601-1 regulatory compliance strategy stress with detailed guidance from a leading expert.
Monday, January 4, 2010
Are You Ready for MDD Amendment Directive 2007/47/EC?
Time is running out – ease your MDD compliance strategy stress with detailed guidance from a leading expert!
The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.
In this audio conference, our speaker provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.
Are You Ready for MDD Amendment Directive 2007/47/EC? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, January 27, 2010. For more details or to register, please visit our site at www.fxconferences.com
The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.
In this audio conference, our speaker provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.
Are You Ready for MDD Amendment Directive 2007/47/EC? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, January 27, 2010. For more details or to register, please visit our site at www.fxconferences.com
Thursday, November 12, 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 conference, 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 the second edition, changes you need to know about 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 is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, November 18, 2009. For more details or to register, 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 conference, 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 the second edition, changes you need to know about 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 is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, November 18, 2009. For more details or to register, please visit our site at www.fxconferences.com
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
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
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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