From: Roberto Pasos [mailto:[email protected]] Sent: Friday, February 12, 2010 3:48 PM To: Roberto Pasos Subject: IEEE PSES Meeting on Tuesday, February 23, 2010, Medical Compliance Management for the Global Market Importance: High IEEE Product Safety Engineering Society Santa Clara Valley Chapter Meeting Date: Tuesday, February 23, 2010 Dinner: 5:30 – 6:45 p.m. Socialize with your colleagues and tonight’s speakers at: El Torito Mexican Restaurant, 2950 Lakeside Drive, Santa Clara, CA 95054 (408-727-4426) -- just two blocks north of the meeting site. No RSVP required. Program: 7:00 – 8:30 p.m. No admission charge. Open to the public. Topic: Medical Compliance Management for the Global Market IEC 60601-1:2005 has been adopted by a number of countries and certification bodies. What does it mean to the product safety practitioner? Medical Device product safety can be a daunting concept, but when considered in an organized manner, it can be managed effectively. This presentation will provide an overview of what is considered in Medical Device product safety certification to the new Standard, for compliance in a multi-country market. Speaker: David McBrayer, P.E. David has over 25 years of professional experience in Product Safety test and certification. Mr. McBrayer became involved when the requirements of each destination country had to be incorporated into a design specification and then harmonized such that the product could be built and marketed with minimal customization for each country. David has experience in telecommunications, ITE and Radiation therapy Medical Devices destined to the North American, European, China and rest-of-world markets. He pursued these efforts at ROLM, IBM and Siemens. Currently, Mr. McBrayer is a Project Engineer at Intertek ETL-Semko. He is a member of the EMC and Product Safety Engineering Societies. David is also a licensed Amateur Extra radio operator and a Certified Radiation Safety Officer. Meeting Site: Applied Materials, Bowers Café, 3090 Bowers Ave, Santa Clara, CA 95054 (map: http://ewh.ieee.org/r6/scv/pses/directs.html) Visit our chapter website: http://www.ewh.ieee.org/r6/scv/pses/index.html Best Regards, Roberto Pasos Product Safety Engineer 684 West Maude Avenue Sunnyvale, CA 94085-3518 [email protected] Ph: 408-245-7800 Fax: 408-245-3499 National Technical Systems Smart Solutions to Tough Challenges sm Visit NTS Online <http://www.ntscorp.com/> | Request a Quote <http://www.ntscorp.com/quick_quote/> | Newsletter Sign Up <https://app.e2ma.net/app/view:Join/signupId:27832> | Customer Survey <http://www.ntscorp.com/customer_service/survey.php> - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher <[email protected]> David Heald <[email protected]>
