June 24, 2015
Company: Philips Ultrasound Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis...
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Company: Mortara Instrument, Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It...
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Company: CareFusion 303, Inc. Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. Recall Number Z-1811-2015 REASON CareFusion...
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Company: Boston Scientific Corporation Date of Enforcement Report 6/24/2015 Class lI: PRODUCT CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 – 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II...
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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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