Industry News: In Brief
Clarifying the MDD
Product classification, compliance with the MDD's essential requirements, and multiple conformity-assessment routes are just some of the issues that have manufacturers burning the midnight oil. Shedding some much-needed light on these and related topics, Gordon R. Higson, consulting director of Quintiles- Medical Technology Consultants (Staines, Middx, UK) and author of The Medical Devices Directives: A Manufacturers' Handbook, will chair three sessions on the Medical Devices Directive at MEDTEC on 21 October in Amsterdam. In addition to the practical matters confronting device manufacturers, Higson will address such recent issues as the French proposal to establish a European medical devices agency and the EU/US Mutual Recognition Agreement that was recently signed. For more information, turn to the MEDTEC section in this issue.
Norton Puts Tubing to ISO 10993 Test
Norton Performance Plastics (Corby, Northants, UK) has received ISO 10993 certification. The standard incorporates a set of criteria to evaluate medical device materials based on their intended use; the tests identify a material's chemical, physical, and biological properties for purposes of biocompatibility assessment. While biological safety testing of the finished product remains imperative, ISO 10993 documentation can simplify the validation process. Norton is reportedly the first tubing supplier to characterize its products according to the international standard. For more information, contact Norton Performance Plastics, 13 Earlstrees Rd., Corby, Northants NN17 4AZ, UK; phone: +44 1536 260789; fax: +44 1536 203427.
Leica Instruments Earns ISO 14001 Certification
Leica Instruments GmbH (Nussloch, Germany) recently earned ISO 14001 certification. The standard requires companies to set up environmental policies, define environmental goals, and establish a program to achieve those objectives. The company looks forward to improving existing environmental policies and developing new ones that will benefit both shareholders and the planet. For more information, contact Leica Instruments GmbH, Postfach 1120, Heidelbergerstr. 17-19, D-69222 Nussloch, Germany; phone: +49 62 24 1430; fax: +49 6224 143200; Internet: http://www.leica.com.
