MEDDEV 2.7/3: Best Practices for Clinical Evaluation Reports

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, May 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, clinical trials, or a combination of the two.

This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.

Labeling for Diagnostic Devices: Best Practices

Since Dec. 7, 2003 in-vitro diagnostic (IVD) products must feature the CE mark to be sold in the European Union. With an ever-growing list of languages to be supported, IVD industry faces a dilemma: How can companies provide the required information in multiple languages, while making the information readable on a variety of sizes of labels?

The use of internationally recognized symbols as a substitute for text has been actively promoted to provide users with a uniform method of obtaining product information. Yet many diagnostics companies are struggling with the issues that surround multilingual label design and international symbology.

Labeling for Diagnostic Devices: Best Practices was presented by Andres Heuberger, President, ForeignExchange Translations and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

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

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

Preparing the Clinical and Regulatory Master Plan

Developing an accurate clinical and regulatory master plan is the key to getting any new drug or device product to the global marketplace quickly and in a cost-efficient manner. The master plan provides an invaluable roadmap of what needs to be done, and will also be used as a business plan in dealings with your notified body and potential investors. In this audio conference, our speakers discuss not just planning for CE marking, but incorporating the overall global market access into one plan. Attendees learn how key parameters and claims are defined, which is an important starting point.

The presentation also covers how to ensure compliance throughout the regulatory pathway to the global market, and how to ensure there is sufficient data available for immediate success of your products in global markets.

Preparing the Clinical and Regulatory Master Plan is being presented by Efraim Roe Kozorovitsky & Dr. Sunita Ahir, Executive Director, Medical Devices & Manager, Regulatory Affairs, with Premier Research and airs on Thursday, September 24, 2009. For more details or to register, please visit our site at www.fxconferences.com

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements

The $9 billion U.S. in vitro diagnostics (IVD) industry is ill prepared to meet the strict new regulations contained in the European Union's new IVD Directive. With only four business quarters left before the December 2003 deadline, IVD companies are realizing that translation is critical to earning the CE mark.

Manufacturers that lack effective plans for complying with the language requirements of the directive risk losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews present new challenges for the majority of diagnostics manufacturers who are dealing with non-English texts for the first time.

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements was presented by Andres Heuberger, President, with ForeignExchange Translations, Inc. and was previously recorded. For more details, or to download this conference please visit our site at www.fxconferences.com

Labeling for Diagnostic Devices: Best Practices

Since Dec. 7, 2003 in-vitro diagnostic (IVD) products must feature the CE mark to be sold in the European Union. With an ever-growing list of languages to be supported, IVD industry faces a dilemma: How can companies provide the required information in multiple languages, while making the information readable on a variety of sizes of labels?

The use of internationally recognized symbols as a substitute for text has been actively promoted to provide users with a uniform method of obtaining product information. Yet many diagnostics companies are struggling with the issues that surround multilingual label design and international symbology.

Labeling for Diagnostic Devices: Best Practices was presented by Andres Heuberger, President, with ForeignExchange Translations. For more details or to download this event, please visit our site at www.fxconferences.com

Taking the Literature Route for Clinical Evaluations

Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, a clinical trial or a combination of the two.

This audio conference focuses on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation highlights pitfalls and best practices, and describe Medical Device Directive (MDD) requirements concerning clinical evaluations. This presentation also discusses use of the clinical literature review as a tool for post-market surveillance and as an input into risk management processes.

Taking the Literature Route for Clinical Evaluations was presented by Carol Houts, Director of Regulatory, Quality and Safety Concerns, with Pleiad and aired on 2008-07-24. This audio conference is available for download 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

CE Marking: 7 Steps to Getting Started in Europe

With a population approaching a half-billion people, the EU represents arguably the most lucrative market today. However, before any medical device company can sell in Europe, it must first obtain the CE Mark. The process of obtaining approval to affix the CE Mark to your product differs significantly from the US FDA system.

This presentation covers the basic steps companies need to follow in obtaining the CE Mark, including a discussion about ISO 13485:2003 and how it differs from FDA Good Manufacturing Practices (GMP), issues related to language translation and labeling, creation of a Technical File and how this differs from the FDA 510(k) application, dealing with Notified Bodies, selecting an Authorized Representative and an overview of the costs and timelines involved in achieving certification.

CE Marking: 7 Steps to Getting Started in Europe was recorded on 2007-04-03 and is now available for download at www.fxconferences.com

Monitoring Essentials for International Medical Device Trials

The FDA publishes warning letters on its website, and these are increasingly concerned with the monitoring of medical device clinical studies. It is clear that some device manufacturers are finding it difficult to comply with the FDA's current guidance and regulations governing the monitoring of medical device clinical trials. In Europe, monitoring standards are similar but there is often a lack of clarity of what is expected because the audience for the clinical trial application (the competent authorities) and the CE marking dossier (the notified bodies) is different.

In this presentation, Dr. Helen Colquhoun will summarize the regulations and official guidance governing the monitoring of medical device clinical trials in the USA and EU. She will also provide the audience with the essentials necessary to ensure compliance with these regulations, including giving practical examples of what monitors need to do at site. Dr. Colquhoun will also cover how to deal with difficult investigators and sites that are unwilling to comply with regulatory standards. A discussion will follow on the consequences of non-compliance, as well as how to prepare for a monitoring audit by the FDA. Dr. Colquhoun will also discuss how clinical research departments need to be resourced to deal adequately with monitoring demands. The presentation will be illustrated by real-life examples.

Monitoring Essentials for International Medical Device Trials is presented by Helen Colquhoun, MD, CEO, Pleiad Devices. For more details on this presentation, please visit our web site www.fxconferences.com

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements

Back in 2002, the $9 billion U.S. in vitro diagnostics (IVD) industry was ill prepared to meet the strict new regulations contained in the European Union's IVD Directive. IVD manufacturers were realizing that translation is critical to earning the CE mark.

Manufacturers that lacked effective plans for complying with the language requirements of the directive risked losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews presented new challenges for the majority of in vitro diagnostics manufacturers who were dealing with non-English texts for the first time.

This audio conference is presented by Andres Heuberger of ForeignExchange Translations. To learn more, visit www.fxconferences.com.