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

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

Good Reprint Practices: What the FDA Says Now

After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.

In this audio conference, our speaker discusses the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.

Good Reprint Practices: What the FDA Says Now was presented by Robert J. Klepinski, with Fredrikson & Byron and aired on 2008-09-04, and is available at www.fxconferences.com

Software as a Device: What You Need to Know About the New MDD

The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD: 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.

It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.

Software as a Device: What You Need to Know About the New MDD was presented by Eric Henning, Senior Project Manager, with KEMA. To purchase a download of this event or for more details, please visit our site at www.fxconferences.com

Managing Global Market Research for Consistency and Insight

Medical companies are increasingly sponsoring global research projects – but is this research effective? How can cultural and linguistic differences be managed to ensure the integrity of the result? Are differences between cultures just skin deep or do they extend to personality? How can we create research metrics that will have consistent meaning around the world? In this Webinar we will provide understanding of these issues and tools for managing global research projects.

Managing Global Market Research for Consistency and Insight was presented by Peter Simpson, President, with Segmedica and aired on 2008-11-12. For more details or to purchase the recording of this event, please visit our site www.fxconferences.com

Industry Update: Where Do We Stand With IEC 60601-1 3rd Edition?

IEC 60601-1 is the cornerstone standard for medical electrical devices, yet development and adoption of the latest edition has been a long, complicated process. Three years after publication, there is still mass confusion over the ever-changing international and regulatory requirements impacted by the 3rd edition of IEC 60601-1. What is the best strategy for your company when it comes to designing your product to IEC 60601-1? Should you design to 2nd or 3rd edition, or both? The answer depends on where and when you will be selling your product!

In this audio conference, Leo Eisner provides a status update on IEC 60601-1 3rd edition, and discusses planned revisions, important regulatory dates related to the standard, and how the collateral and particular standards are aligned to 3rd edition. There are major changes from the 2nd edition, changes you need to know about in order to comply. Get the answers to your 60601-1 compliance questions from a leading expert!

Industry Update: Where Do We Stand With IEC 60601-1 3rd Edition? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Tuesday, February 10th, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.

FCPA Compliance Strategies for Medical Device & Pharma Companies

The Foreign Corrupt Practices Act (FCPA) has had a major impact on the way companies conduct business abroad. A U.S. anti-corruption law jointly enforced by the Department of Justice and the Securities and Exchange Commission, its main provisions deal with improper payments to foreign officials and questionable accounting practices used to hide them. Violating the FCPA can result in both criminal and civil penalties, and the requirements are complex, applying to both companies in the U.S. and foreign-based companies subject to U.S. securities laws. Past enforcement actions have crossed industry boundaries and included the pharmaceutical industry. Lately, there has been an increase in FCPA enforcement activity in the medical device industry as well.

In this audio conference, our speakers combine their experience with real-world case studies to provide a clear background on the FCPA requirements and enforcement trends, along with practical compliance strategies to keep device and pharma companies from running afoul of the law.

FCPA Compliance Strategies for Medical Device & Pharma Companies is being presented by Bethany Hills & Michelle Merola, with Hodgson Russ LLP and airs Wednesday, April 1, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Successful Medical Device Approvals in China

With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving. In this audio conference, our speaker discusses the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation also provides examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.

Successful Medical Device Approvals in China was presented by Janice Ma, Managing Director, with ChinaGate and aired June 19th, 2008. For more details, or to listen to a sample clip, please visit our site www.fxconferences.com

The New Europe: Overview for Device Manufacturers

The new 25-member European Union has its roots in World War II and the Cold War. It is a collection of 25 very different markets in terms of size and development.

Although European law and policy attempts to create a huge single market of more than 450 million people, in reality much of that market is still highly segmented. The legacy of Communism still weighs heavy in most of the new members that joined in 2004, affecting the ability of Western medical device manufacturers to do business and deal with regulatory issues in these countries.

The New Europe: Overview for Device Manufacturers was presented by Mika Reinikainen, VP, of Quintiles Consulting on 2004-09-16. For more information, or to download this product, please visit our site www.fxconferences.com