All, There will be a Northeast Product Safety Society meeting on tomorrow, January 28, at EMC Corporation's Customer Briefing Center in Hopkinton, MA. A social hour with light refreshments will begin at 7:00 PM and the technical meeting will start at 7:30 PM. Frank O’Brien, Senior Staff Engineer for UL Chelmsford, will be presenting this month’s technical topic concerning EU Directives for medical devices. Frank will provide an overview of the EU Directives for medical devices, the CE conformity assessment and declaration process, and how European product safety standards fit within this process. The presentation will include a comparison of the EU conformity assessment process with that of the FDA, and various product safety certification organizations. If you will be in the area, please feel free to join us as NPSS membership or advanced notice is not required.
Frank O'Brien is a Senior Staff Engineer at Underwriters Laboratories, Chelmsford, MA. Frank has experience working with manufacturers and other test laboratories from all over the world, while living 6 years in Germany, 5 years in the US, on the west coast, and 12 years on the east coast. Frank's expertise includes the EU MDD, EU IVDD, Canadian MDCAS, FDA 510(k) AP program, ISO 13485, ISO 14971, IEC 60601, IEC 61010, and IEC 60950. Further information about the Northeast Product Safety Society and how to become a member is available at http://www.nepss.org. You can also contact one of the NPSS officers via links on the NPSS web site. Directions: >From Route 495 North or South take exit 21B to West Main Street. Counting the first traffic light as the traffic light at the off ramp >from Route 495 South. At the second traffic light, turn left on to South Street (Note: This is on South direction side of Route 495). EMC Corporation is the second driveway on the right. Matt Campanella NPSS Secretary Compliance Engineer Motorola, Inc. Broadband Communications Sector 111 Locke Drive Marlborough, MA 01752 (508) 786-7629 Direct (508) 786-7500 Main (508) 480-6332 Fax [email protected] email This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
