Medical Device Link.

Originally Published EMDM October 2003

INDUSTRY NEWS

ASTM Increases Transparency in Standards Development Process

An Internet-based system initiates, develops, and tracks draft standards and revisions before and during their balloting stage. Launched by ASTM International (Hitchin, Herts, UK), the Work Item Registration system can be accessed at the society’s Web site, www.astm.com. Users can sign up for a free e-mail advisory service that provides notification of new work items in their area of interest. The system also provides ASTM members with access to every stage of the standards development process. 

On-Line Information for Fibre-Reinforced Plastics

The search for reliable information on materials and their applications will become faster and more accurate, promises M-Base Engineering + Software GmbH (Aachen, Germany). The first modules of its database (www.n-fibrebase.net), dedicated to natural fibres and natural-fibre-reinforced plastics, are already accessible on-line. Information about suppliers and prices, as well as key values for dimensioning natural-fibre-reinforced parts, is readily available. The reference parts module describes existing applications where natural-fibre-reinforced plastics are the material of choice. The market module contains information regarding producers and suppliers of natural fibres and semifinished products. 

Risk Management Kit On-Line

CE marking risk management information is currently available on-line from Crimson Medical Translation (San Francisco, CA, USA). The kit is based on translation and risk management requirements outlined in the Medical Devices and In Vitro Diagnostic Directives and the ISO 13485 and ISO 14971 standards. A key component of the CE Labeling Risk Management kit is the process validation form. Designed to supplement the traditional translation certificate, the form solicits vendor sign-offs for each required process step, thereby avoiding process fraud. The kit is available for download at the company’s Web site (www.medical-language.com/biomednews). 

Web Seminars Hosted by SPSS Science

A series of on-line seminars is offered by SPSS Science (Düsseldorf, Germany) in cooperation with software provider Webex. The so-called webinars are suitable for international training sessions and product demonstrations. They will help demonstrate the basic techniques of the company’s software programs SigmaPlot and SigmaStat. During the 
30- to 60-minute presentations, participants communicate with a trainer via telephone and e-mail, adding an interactive element to the training sessions. The scheduled webinars are held in English or German. A schedule of SPSS Science 
e-seminars and on-line registration is available at www.spssevents.webex.com. 

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