June 12, 2013
Company:Symbios Medical Products.Date of Enforcement Report 6/12/2013 Class I: PRODUCT Part 510031 Disposable Single Infusion Pump, quantity Includes… TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO… found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 510042 – BP, w/ Epidural...
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Company: American Optisurgical.Date of Enforcement Report: 6/12/2013 ClassL Ill: PRODUCT Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. Recall Number Z-1441-2013 REASON Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different...
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Company: American Optisurgical. Date of Enforcement Report: 6/12/2013 Class ll: PRODUCT American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. Recall Number Z-1516-2013 REASON The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board....
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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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