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 Salma Michor. Show all posts
Showing posts with label Salma Michor. Show all posts
Friday, March 23, 2012
Wednesday, December 7, 2011
eLabeling Medical Devices for the EU Market
is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Tuesday, January 10th, 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.
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.
Wednesday, April 13, 2011
The New Rules for Safety and Performance of Medical Devices in the EU
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Thursday, May 19th, 2011. For more details, or to register please visit our site at www.fxconferences.com
In the EU rules relating to the safety and performance of medical devices were harmonized in the 1990s. The legal framework consists of three main directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
The revised MDD 93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset of more rigorous regulations in the EU. Manufacturers must comply with the new requirements for both new products and products already on the market. This audio conference provides an overview of the latest updates introduced by Directive 2007/47/EC, and what they mean for device manufacturers.
In the EU rules relating to the safety and performance of medical devices were harmonized in the 1990s. The legal framework consists of three main directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
The revised MDD 93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset of more rigorous regulations in the EU. Manufacturers must comply with the new requirements for both new products and products already on the market. This audio conference provides an overview of the latest updates introduced by Directive 2007/47/EC, and what they mean for device manufacturers.
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.
Thursday, July 29, 2010
Vigilance Planning for Device Trials Under the Revised MDD
is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Wednesday, September 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
Manufacturers placing medical devices on the European market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS).
In the EU the medical devices directive (MDD) establishes the principal mechanisms for providing feedback about medical devices. The revision of the MDD has had an impact on clinical evaluations/investigations and vigilance reporting. The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New clauses added to Annex X of the MDD stipulate that all serious adverse events must be fully recorded and immediately reported to all Competent Authorities of the Member States in which the clinical investigation is being performed.
This audio conference takes a detailed look at EU provisions for post-marketing surveillance and vigilance for medical device trials under the revised Directive.
Manufacturers placing medical devices on the European market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS).
In the EU the medical devices directive (MDD) establishes the principal mechanisms for providing feedback about medical devices. The revision of the MDD has had an impact on clinical evaluations/investigations and vigilance reporting. The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New clauses added to Annex X of the MDD stipulate that all serious adverse events must be fully recorded and immediately reported to all Competent Authorities of the Member States in which the clinical investigation is being performed.
This audio conference takes a detailed look at EU provisions for post-marketing surveillance and vigilance for medical device trials under the revised Directive.
Wednesday, March 3, 2010
Medical Device Vigilance Planning under the Revised MDD
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Tuesday April 13, 2010. For more details, please visit our site at www.fxconferences.com
Manufacturers placing medical devices on the market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS). In the EU the medical device directives (MDDs) establish the principal mechanisms for providing feedback about medical devices. Provisions regarding vigilance and PMS are outlined in various annexes to the MDDs: Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD), as amended; and In Vitro Device Directive (IVDD), as amended.
This audio conference provides information on various aspects of the legislation and how it is affecting medical device manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
Manufacturers placing medical devices on the market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS). In the EU the medical device directives (MDDs) establish the principal mechanisms for providing feedback about medical devices. Provisions regarding vigilance and PMS are outlined in various annexes to the MDDs: Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD), as amended; and In Vitro Device Directive (IVDD), as amended.
This audio conference provides information on various aspects of the legislation and how it is affecting medical device manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
Thursday, December 17, 2009
EU Medical Device eLabeling, Compliance & Software Requirements
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 proposed 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.
EU Medical Device eLabeling, Compliance & Software Requirements is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Wednesday, January 13, 2010. For more details or to register, please visit our site at www.fxconferences.com
However, the latest proposed 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.
EU Medical Device eLabeling, Compliance & Software Requirements is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Wednesday, January 13, 2010. For more details or to register, please visit our site at www.fxconferences.com
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.
Friday, August 21, 2009
Implementing a Quality Management System: ISO 13485
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements. One of the main objectives of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes many of the elements of ISO 9001 but excludes some aspects not appropriate as regulatory requirements. ISO 13485:2003 is applicable to all medical device manufacturers, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.
This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.
Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com
If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.
This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.
Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com
Thursday, April 30, 2009
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 proposed 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.
Device e-Labeling & Regulatory Compliance in the EU is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, June 18, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
However, the latest proposed 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.
Device e-Labeling & Regulatory Compliance in the EU is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, June 18, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
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