10/30/2006

UL International Germany GmbH

UL to showcase certification procedure for worldwide market introduction of medical devices

UL International Germany and UL Medical Services will showcase UL’s comprehensive certification services for the medical sector at Medica, the international medical trade fair in Düsseldorf from November 15 through 18, 2006 (Hall 13, Stand D30). UL International Germany GmbH is the German subsidiary of Underwriters Laboratories Inc., a United States-based leader in product compliance. As a Notified Body, UL Medical Services offers manufacturers of medical devices the opportunity to subject products to a conformity assessment procedure in accordance with EU Medical Devices Directive 93/42/EEC. With regard to the certification procedures for medical products UL will place its focus, at Medica, on quality management, risk management, product compliance and global market access. Experts from UL will be on hand to explain to fair visitors the requirements to be met to achieve compliance with the individual standards applicable in the medical sector and to offer in-depth information on introducing medical products to markets in the countries of interest to them.

At the Medica fair in Düsseldorf, UL’s main points of focus will be the quality management system (QMS), the risk management system related to it and the safety testing of medical products. UL will be presenting QMS registration, and explaining testing and certification in accordance with the ISO 9000 standard, which covers general quality management. Another regulation of great significance to QMS is the ISO 13485 standard, which confirms that a company’s processes and procedures meet medical quality requirements. Moreover, UL specialists will explain the risk management system, which is essential to medical products and meets the ISO 14971 standard. A further topic covered by UL at Medica will be medical product safety testing, which is governed, among others, by the IEC standard IEC60601, IEC61010 and international CB certification. The CB Scheme is a special certification procedure the object of which is the mutual recognition of international testing bodies. It is a multilateral agreement that is accepted almost worldwide. At present the network of the CB Scheme comprises 58 product certification organizations and 140 testing laboratories in 43 countries.