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August 30, 2017
30
Aug

FDA Abbott Cybersecurity Safety Communication

August 30, 2017
On August 29, 2017, the FDA issued “Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication.” The full document is at the link provided. Firmware Update to Address Cybersecurity Vulnerabilities in Abbott Pacemakers
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30
Aug

A Collaborative Approach to Test Debt

August 30, 2017
Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...
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30
Aug

Cl II ORA System with VerifEye+ Cart

August 30, 2017
Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery. Recall Number Z-3049-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error...
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30
Aug

Cl II ORA System with VerifEye

August 30, 2017
Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery Recall Number Z-3050-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that...
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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