Optimizing Document Design for More Efficient Translation

is being presented by Amy Maxson, Technical Services Lead, with ForeignExchange Translations and airs on Thursday, December 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com

Product documentation is often designed with little thought to its impact on the translation process. This represents a missed opportunity, since the layout and design of your documentation can have as great an impact on localization cost, turnaround time and quality as the content itself. However, it can be a real headache, trying to fit an ever-increasing number of languages – including double-byte languages – into your Instructions for Use, user manuals, and marketing materials. This audio conference presentation shares best practices and pitfalls to avoid when designing documents that will be translated into other languages. Attendees benefit from the first-hand insight of a veteran localizaton professional discussing how best to create graphics, set margins, select fonts and choose software to get the most out of their translation dollars.

Intended Use & Indications for Use – Does Anyone Know What They Mean? Does FDA?

is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, January 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Intended use. Indications for use. For years FDA has developed working definitions of these two terms, which vary from the definitions included in the regulations. Now FDA is questioning whether new definitions are needed. Previous industry use of the terms was based upon FDA's informal guidance, but if FDA doesn't know what they mean, does anyone?

In this audio conference, regulatory attorney Bob Klepinski discusses both the practical and the theoretical issues surrounding these two important terms and their use. The presentation looks at the statutory and regulatory definitions, and FDA's attempts to define them in guidance for industry. It also looks at what the future might hold, and how companies should proceed in the interim.

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