Martha Feldman Speaks at Medical Device Seminar Series - LifeSciences BC Members Socialize at Inaugural Med Device MinglerOctober 16, 2008With special partners - Canadian Consulate General in Seattle, and Foreign Affairs and International Trade Canada  Martha Feldman offeres her comments on FDA updates to LifeSciences BC members LifeSciences BC was pleased to offer a special workshop focused on recent FDA regulatory updates. Two experienced specialists, Martha Feldman and Bruce Haggar, delivered the most current updates ranging from pre-marketing regulatory affairs, and 510(K) submission, to combined products (drug/biotech-device; device-device) and quality system regulation. For the first time ever, LifeSciences BC hosted a Med Devices Mingler after the seminar. This networking reception provided a great opportunity for medical device companies to connect with their peers and LifeSciences BC’s broader membership as well. Held at the popular Saltlik Steakhouse, members took the opportunity to unwind and build relationships with one another and prospective partners. Look for a repeat of this mingler at future events! Speakers’ Biographies Martha A. Feldman, RAC President, Drug & Device Development Co., Inc. Since 1985, Martha A. Feldman has been President of the Drug & Device Development Co., Inc., a small CRO, where she also serves as Senior Consultant. As a Consultant, Feldman has worked for many start-up and established companies in obtaining product approvals, preparing regulatory strategies, planning for and implementing clinical trials, salvaging and troubleshooting ongoing studies and regulatory plans. She has prepared the regulatory and clinical sections of business plans and has performed due diligence as a third party in acquisitions and in preparation for IPOs. Feldman is an Affiliated Associate Professor of Bioengineering at the University of Washington and an instructor in two certificate programs: Regulatory Affairs and Clinical Trials. She was recognized by the WA State Biotechnology and Biomedical Association as "Regulatory Professional of the Year for 1994" and was the 1997 recipient of the RAPS Greco Award for Industry. In 2005, Feldman was invited by the governments of New Zealand and of Canada to give talks in several cities on FDA requirements in the medical product development and approval processes. She has rehearsed these presentations in front of her dog who has given them two paws up. Bruce Haggar President, MedQ Systems, Inc. Bruce Haggar is currently the president of MedQ Systems, Inc. a leading Biomedical Industry consulting organization. Previously he was President of Bruce Haggar Consulting, Inc., specializing in Process Validation and FDA/Regulatory consulting and auditing. He is widely recognized as one of the nation's experts in process validation, medical device auditing, quality system development, and medical device design control. He is a past Chair of the ASQ/Biomedical Division and the editor of the Biomedical Quality Auditor Handbook. Mr. Haggar is a Biomedical Engineer with experience in a variety of biomedical technology firms in product development, manufacturing, and regulatory/quality assurance. He was a primary developer of the external automatic defibrillator technology in the late 1980's at Cardiac Resuscitator Corporation and First Medical Devices, Inc. He is active in various industry organizations including ASQ Biomedical Division, AAMI, and RAPS. He also served as an Investigator for the U.S. FDA. |
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