Technical Documentation Requirements for Device Approval in the EU

is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Thursday, November 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.

The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.

This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.

Complying with EU Requirements for Medical Device Software

is being presented by Poul Schmidt-Andersen, Managing Partner, with Danish Medical Devices Consulting and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com

This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.

Good Auditing Practices for EU Notified Body Audits

is being presented by Theo Nusselder, Founder & Director, of cePartner4u and airs on Tuesday, March 30, 2010. For more details or to register, please visit our site at www.fxconferences.com

Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.

The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.

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

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

An Introduction to Regulatory Writing: Creating an Effective Message was presented by Nancy Hoft, of Nancy Hoft Consulting and aired 2008-07-16. For more information or to purchase a download of this event, please visit our site www.fxconferences.com

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

An Introduction to Regulatory Writing: Creating an Effective Message is being re-broadcast on Tuesday, October 21st, and is presented by Nancy Hoft, of Nancy Hoft Consulting. For more details or to register, please visit our site at www.fxconferences.com

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

This conference is presented by Nancy Hoft of Nancy Hoft Consulting. For more details please visit our site www.fxconferences.com