April 1, 2015
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body,...
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Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 4/1/2015 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System; — RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation...
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Company:GE Healthcare Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour,...
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Company:Brainlab AGDate of Enforcement Report: 4/1/2015 Class lI: PRODUCT ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. Recall Number Z-1316-2015 REASON The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.. RECALLING FIRM/MANUFACTURER...
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Company:CareFusion 303, Inc.Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT Alaris PC units, Model No. 8015. Infusion pump. Recall Number Z-1311-2015 REASON CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the “Power-On Self Test” due to a keypad issue. 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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