Day

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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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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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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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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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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