Originally Published EMDM
May 2003
INDUSTRY NEWS
Workshop Examines Nuts and Bolts of ISO 13485 |
| Ed Kimmelman |
The new ISO 13485 standard, “Quality Management Systems—Medical Devices—System Requirements for Regulatory Purposes,” is intended to reflect the current global level of quality system regulation. In addition to its focus on regulatory issues and meeting customer requirements, the standard emphasizes a “process approach” and maintenance of procedural documentation. Ed Kimmelman, who is intimately familiar with the standard as convener of ISO/TC 210 Working Group 1, is slated to lead a three-hour workshop on the new standard at MEDTEC Ireland.
Following a review of regulatory matters, Kimmelman will explain why ISO 13485 is being revised, the key issues the revision addresses, and how the standard contrasts with US FDA’s QSR. Kimmelman will also discuss practical steps manufacturers can take to evaluate the compliance of their quality systems. His goal is to ensure that delegates leave the conference with a thorough understanding of ISO 13485.
MEDTEC Ireland will also address several other topics of interest to medical device OEMs, including emerging technologies in biomaterials. Running parallel with the conference, a tabletop exposition will provide attendees with an opportunity to source products and services from more than 50 suppliers.
MEDTEC Ireland is produced and managed by Canon Communications llc, which publishes EMDM. The event will be held at the Radisson SAS hotel in Galway on 17 and 18 September. For more information, visit
www.medtecireland.com.
Copyright ©2003 European Medical Device Manufacturer
