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TEL: (303) 771-0047 FAX: (303) 771-0047 Email: dennisbruner@att.net Expertise: Quality/Regulatory Compliance: FDA Medical Device Regulatory Compliance and Quality System Consulting. Expert Witness: Medical devices used in Cardiovascular Surgery, Hemodialysis, Surgical Blood Salvage, Physiologic Pressure Monitoring and Pulmonary Disease. Experience: 30+ years of medical device manufacturing (Quality, Regulatory Compliance, ISO 9001, CE Marking, Top Management) experience. Products Liability experience in over 40 medical device law suits. Memberships: NAFE (Sr. Member), NSPE, ASME, AAMI, ASQ, RAPS. Board Certified Diplomate in Forensic Engineering by NAFE, a CASB Member Board. Post Doctoral Research: Harvard Medical School. |
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