Blood borne pathogens seminar. Blood borne infections and tuberculosis: management of occupational exposure and isolation precautions Valerie Fletcher, M.D. Blood borne pathogens. Microorganisms that are present in human blood and can cause disease in humans.
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FDA's role in the innovation and evaluation of evolving computer-aided diagnosis (CAD) solutions. Kyle J. Myers, Ph.D. Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health
951 views • 63 slides
The Impact of Regulations on Medical Device Design. Richard C. Fries, PE, CRE Manager, Corporate Reliability Engineering Baxter Healthcare Round Lake, Illinois. Extra Activities for Regulated Industries. Develop and maintain a Quality System Product Documentation Design History File
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STOP the KILLING Peter Pronovost, MD, PhD. Please answer each question with a score of 1 to 5. 1 is below average, 3 is average and 5 is above average . How smart am I How hard do I work How kind am I How tall am I How good is the quality of care we provide.
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Blood Establishment Computer Software (BECS). Michael Gorman, BA, MT(ASCP)SBB Consumer Safety Officer, CBER, OBRR, DBA September 15, 2009. Outline. What is a BECS? Regulations for Manufacturers Manufacturers: Medical Device 510(k) Clearance Regulations for Users Validation
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Entering the North American Market. The Regulatory Landscape: Device Regulation in Canada Nancy Ruth Director, Medical Devices AdvaMed September 21, 2008. Authority from Food and Drug Act Health Canada - regulator Mandate: protect Health of citizens
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Public Workshop: Quarantine Release Errors in Blood Establishments September 13, 2011 QREs Past, Present and Future. Sheryl A. Kochman Deputy Director Division of Blood Applications OBRR/CBER. Overview. Reason for the Workshop Definitions Past Present Future. Reason for the Workshop.
410 views • 19 slides
Deep Brain Stimulation for Psychiatric Disorders. Jahdiel Franco BME 482. What is DBS?. A surgically implanted medical device called a brain pacemaker. Sends electrical impulses to the brain.
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Patient Safety and Medical Devices Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT. What Makes a Good Medical Device Adverse Event Report?. Complete Device Narrative Information. Device Identifier data Device Type e.g. Infusion Pump Implantable insulin Patient controlled analgesia
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Towards crucial oral care of long term bed ridden elderly. -Need for a medical device. 4 th WHO Global Forum on Medical Devices, Vizag , India , 15 th December 2018, 14.30 PM. Dr. Steward Gracian BIRAC SIIP Fellow 2018-19 KIIT TBI, Bhubaneswar.
358 views • 12 slides
Machine Learning Regulated by the FDA. Pilar N. Ossorio , Ph.D., JD April 5, 2019. FDA regulates medical device software.
445 views • 11 slides
Statement of the Medical Imaging Contrast Agent Association. FDA Public Hearing on Combination Products November 25, 2002. 1. Scope of Combination Product Regulation. Concomitant use products are not necessarily combination products. Definition of combination product:
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