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November 11, 2015
11
Nov

$SoftwareCPR Go-Live Checklist Training Example$

November 11, 2015,
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. A sample checklist for releasing or updating software is at the link provided. GoLiveiChecklistTrainingExample111115
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11
Nov

Cl II Triton Smart Ankle iOS Galileo applcation

November 11, 2015
Company: Otto Bock Healthcare GmbHG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66* Triton Smart Ankle. Recall Number Z-0209-2016 REASON Otto Bock Healthcare GmbH has identified a software issue where the foot can produce an undesired response (can move into dorsiflexion)...
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11
Nov

Cl II Philips HeartStart MRx

November 11, 2015
Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A Recall Number Z-0204-2016 REASON 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and...
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11
Nov

1 FS Chemistry System Cl II Ortho VITROS 5

November 11, 2015
Company: Ortho-Clinical Diagnostics Date of Enforcement Report 11/11/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes...
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11
Nov

GE Centricity PACS IW Cl II

November 11, 2015
Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this...
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11
Nov

GE Centricity Universal Viewer Cl II

November 11, 2015
Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system...
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11
Nov

Cl II Brainlab Digital Lightbox

November 11, 2015
Company: Brainlab AG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It...
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11
Nov

Cl II AMSCO Small Steam Sterilizers

November 11, 2015
Company: Steris Corporation Date of Enforcement Report 11/11/2015 Class lI: PRODUCT AMSCO 400 and AMSCO C Small Steam Sterilizers Recall Number Z-0210-2016 REASON In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer...
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11
Nov

HeartStart MRx monitor/defibrillator Cl II

November 11, 2015
Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the...
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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

Need info?  Email us at training@softwarecpr.com

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