Industry Update: EU Labeling for Medical Devices

Many companies believe that by simply having the CE mark on their products they are in position do business in Europe. However, things are not always that straightforward. They tend to forget that the European Union is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with national language requirements. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

This audio conference discusses these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels. In addition, the presentation covers proper language for the intended users in conjunction with risk management.

Industry Update: EU Labeling for Medical Devices was presented by Dr. Jaap Laufer, Vice President, Public & Regulatory Affairs, with Emergo Group and aired on 2009-03-12. For more details or to download this event, please visit our site at www.fxconferences.com

EU Device Labeling: Issues and Requirements

For many companies, achieving ISO 13485 certification, applying the CE mark and finally exporting to Europe is a great victory. However, many companies forget that the EU is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with language requirements and the use of symbols for each country. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

In this presentation, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels.

EU Device Labeling: Issues and Requirements was presented by Dr. Jaap Laufer, .P. Public & Regulatory Affairs, with Emergo Group Inc. and aired on 2007-09-06. For more details, or to download this audio conference please visit our site at www.fxconferences.com

Industry Update: EU Labeling for Medical Devices

Many companies believe that by simply having the CE mark on their products, they are in position do business in Europe. However, things are not always that straightforward. They tend to forget that the European Union is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with national language requirements. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

In this audio conference, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels. In addition the presentation covers proper language for the intended users in conjunction with risk management.

Industry Update: EU Labeling for Medical Devices is being presented by Jaap Laufer, Vice President, Public & Regulatory Affairs, with Emergo Group and airs on Thursday, March 12th, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

Industry Update: Vigilance for Medical Devices

After a few quiet years, several important European regulatory changes have occurred that will affect most medical device manufacturers. Most notably, Competent Authorities are now expecting manufacturers to have a good understanding of post-market surveillance, including vigilance. Notified Bodies and Competent Authorities alike are starting to make this a key element of their inspections and companies must be prepared.

In this presentation, Dr. Loh discusses important new revisions to MEDDEV 2.12-1 rev 5, Guidelines on a medical devices vigilance system, published in April 2007. The guidelines entered into force on January 1st, 2008.

Industry Update: Vigilance for Medical Devices was presented on 2007-06-21 and is available to download to www.fxconferences.com

Risk Management Best Practices for Medical Devices

Managing risk has always been an integral part of medical device development, but is now becoming more integrated with quality management systems. Previous experience with “risk assessment” had been the application of risk analysis to determine specific risks associated with a device. This is no longer the case with a quality management system such as ISO 13485 and the recently updated ISO 14971 standard defining and clarifying the risk management process.

This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.

Risk Management Best Practices for Medical Devices is being presented by Richard Vincins, Senior Consultant, with Emergo Group and airs on Thursday, January 22, 2009. For more details, or to register for this audio conference, please visit our site www.fxconferences.com