October 9, 2019
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Denterprise International, Inc., 100 E. Granada Blvd. Ste. 219, Ormond Beach, Florida, from May 1, 2019 to May 6, 2019. During the inspection, an FDA investigator determined that your firm is a specifications developer, manufacturer of the...
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Company: WOM World of Medicine AG Date of Enforcement Report: 10/9/2019 Class II PRODUCT Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. Recall Number: Z-2767-2019 REASON The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk....
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Company: ELITech Group B.V. Date of Enforcement Report: 10/9/2019 Class III PRODUCT Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 – Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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