Originally Published MPMNMay2003

E-NEWS

On-Line Seminars Provide Regulatory Compliance Information

by ZacharyTurke

The ETL Semko division of Intertek Testing Services (Boxborough, MA) has announced the opening of the Intertek Education Center, a Web-based resource featuring an ongoing series of live seminars for compliance engineers in the medical field. Accessible through a link on the company's home page at www. etlsemko.com, these seminars are designed to increase the understanding of current regulatory requirements and facilitate transitions to future standards. "By attending these virtual lectures, medical device engineers and manufacturers [are] taking a proactive stance toward understanding this ever-changing field," says director of business and medical technology DonSherratt.

The first lecture in this series, "The In Vitro Diagnostics Directive: An Inside View," provided a comprehensive look at IVD requirements for CE marking. Originally broadcast on March 20, the seminar was led by Sherratt and offered engineers useful strategies for making the testing process smoother, faster, and more cost-efficient. The lecture was immediately followed by a live question-and-answer session where engineers were allowed to address their specific concerns. The entire broadcast has been archived to allow viewing by parties who were unable to attend.

Other seminars ETL Semko has hosted include "Understanding Bluetooth," and a two-part seminar, "The Basics of Compliance," is scheduled for April 2 and 30. Topics to be covered in the futureinclude ISO 13485:2003 transitioning, FDA 510(k) reviews, and Asian-market entry requirements. All seminars begin at 12:00 p.m. (EDT).

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