is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, March 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Showing posts with label e-labeling. Show all posts
Showing posts with label e-labeling. Show all posts
Friday, March 23, 2012
Thursday, January 20, 2011
eLabeling Medical Devices for the EU Market: Issues and Advantages
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, February 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Friday, September 10, 2010
Regulatory and Practical Implications of e-Labeling for IVDs in Europe
is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, of Qarad and airs on Tuesday, October 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com
With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.
In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.
With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.
In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.
Friday, November 13, 2009
Friday special - save 75% on "Device e-Labeling & Regulatory Compliance in the EU"
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy.
The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.
However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.
However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.
But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
Monday, July 27, 2009
Regulatory and Practical Implications of e-Labeling for IVDs in Europe
With more than 20 official languages in the European Union, manufacturers often encounter challenges when providing paper instructions for use by traditional means. In MEDDEV 2.14/3, the European Commission gives guidance to manufacturers of in vitro diagnostic devices regarding the supply of instructions for use, which can now be provided by alternative means such as a dedicated website. However, there are strict conditions which apply to such websites, including the requirement that the manufacturer also provide a toll-free telephone number for customer support.
In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.
Regulatory and Practical Implications of e-Labeling for IVDs in Europe is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, Qarad and airs on Tuesday, September 8, 2009. For more details, please visit our site at www.fxconferences.com
In this conference, our speaker details the IVD e-labeling requirements as defined in the MEDDEV guidance, and explains the challenges posed by the implementation of e-labeling solutions that comply with those requirements.
Regulatory and Practical Implications of e-Labeling for IVDs in Europe is being presented by Dr. Dirk Stynen, Founder & Principal Consultant, Qarad and airs on Tuesday, September 8, 2009. For more details, please visit our site at www.fxconferences.com
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