March 30, 2016
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/30/2016 Class lI: PRODUCT syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional proceduress. Recall Number Z-1232-2016 REASON After...
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Company: Roche Diagnostics Operations, Inc. .Date of Enforcement Report 3/30/2016 Class lI: PRODUCT cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. Recall Number Z-1233-2016 REASON Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back...
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Company: MITSUBISHI HEAVY INDUSTRIES, LTD.,.Date of Enforcement Report 3/30/2016 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. Recall Number Z-1244-2016 REASON Due to Operator Console software anomaly, a change in treatment completion status of...
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Company: CareFusion 303 Inc..Date of Enforcement Report 3/30/2016 Class lI: PRODUCT Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092. Recall Number Z-1239-2016 REASON CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a “System Error” or “Missing Battery” error code (120.4630). RECALLING FIRM/MANUFACTURER CareFusion...
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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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