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For more information on this webinar click the link provided.
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Bristol, UK. Now in its fifth year, the mission of the High Integrity Software conference is to share challenges, best practice and experience between software engineering practitioners. The conference features talks from industrial and academic specialists which disseminate experience and knowledge of important techniques and methods that are applicable across industry sectors. For more information...
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Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided. RAPS Regulatory Convergence
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Philadelphia, PA: The MedTech Conference features senior level politicians and executives and a wide array of educational programming. For more information, click the link provided.  
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AAMI TIR 57 on medical device cybersecurity risk management will be published in 2016.  Status: The TIR has been recognized by the FDA before it was even been made available for purchase by AAMI. The TIR is now available for purchase from AAMI.
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/docs/scpred/AAMI-BITarticle_Ten_Questions_With_Alan_Kusinitz.pdf
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ECRI Institute published its Top 10 Patient Safety Concerns for Healthcare Organizations to give healthcare organizations a gauge to check their track record in patient safety. The list originally appeared in its Healthcare Risk Control (HRC) System newsletter, the Risk Management Reporter, and is reprinted in this report. The list is partly based on more...
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Alan Kusinitz Managing Partner of SoftwareCPR accepted appointment to the Biomedical Instrumnetation and Technology journal editorial board. Alan authored a number of articles for this journal and performed peer revieiws for the journal over the years.
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The link provided is to a white paper prepared by Northwest Cadence regarding use of Microsoft Visual Studio to aid in compliance with FDA requirements. Food and Drug Administration (FDA) Compliance with Visual Studio 2010
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AAMI recently published “Assessing a Hospital’s Medical IT Network Risk Management Practice with 80001-1” in Biomedical Instrumentation & Technology (BI&T). The article reports on an actual hospital network/health IT assessment using 80001-1 as one of the tools for the assessment.
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A workshop with approximately 80 invited medical wireless experts was held in October 2012. This report, at the link provided, documents the discussion and outcomes of this workshop. A follow-up meeting is planned for March 2013. 2012_Wireless_Workshop_Publication
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http://www.aami.org/meetings/courses/trainer.details.html
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http://lms.ulknowledgeservices.com/catalog/display.resource.aspx?resourceid=411809
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The Association for the Advancement of Medical Instrumentation (AAMI) is reorganizing its committee structure related to Software, Health IT, networks and related topics by forming a Software and Health Information Technology (SWIT) committee to oversee all related standards activities. The current plan is that this committee will coordinate all work in the Software, IT, MDDS,...
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The pdf at the link provided is a reprint of 2 articles entitled “Sensible Software Testing” parts 1 and 2, with the permission of the author Sean Beatty of High Impact Services. Mr. Beatty was a member of the working group that developed AAMI TIR32: Medical Device Software Risk Management. He is very experienced in...
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The pdf at the link provided is a reprint of an article entitled “Sensible Software Testing” with the permission of the author Sean Beatty of High Impact Services. Mr. Beatty was a member of the working group that developed AAMI TIR32: Medical Device Software Risk Management. He is very experienced in embedded programming and this...
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With the permission of Oliver Christ of PROSYSTEM AG in Hamburg, Germany, you can view or download slides at the link provided entitled: Cost-effective Application of Usability Engineering and Risk-Management. Oliver and his partner are heavily involved in standards and these slides provide an excellent overview of medical device usability, software, and risk management standards...
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Larry Pilot, lead attorney on behalf of Utah Medical, recently gave a presentation on this case. His slides are available at the link provided with his permission. In this case FDA cited Utah Medical Products for process and production software validation issues and was seeking an injunction. Utah Medical won in court and FDA decided...
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“A Methodology for Safety Case Development” was the result of a research grant. It discusses development of safety cases. Essentially development of justification for the safety of software in a given system/use. While FDA requires risk and software hazard analysis there is significant value, in our opinion (SoftwareCPR), in constructing rationale that demonstrates safety rather...
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http://www.asq.org/ed/courses/descriptions/buildsoftwareq.html
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With the permission of AAMI attached is a pdf of the AAMI newsletter article summarizing the software session of the March 2000 International Software Standards Conference. AAMI 300 software article
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The New England Biomedical Discussion Group held a half-day seminar on Risk Management. Alan Kusinitz of SoftwareCPR gave a presentation on Software Risk Management. The newsletter summary of the seminar is at the link provided: Intro to Risk Management Article
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The paper at the link provided was written by Mark Paulk of the SEI. It compares ISO 9001 and the Capability Maturity Model (CMM). Although there are some differences between ISO 9001 and the FDA Quality System Regulation, both in content and enforcement, this paper may be helpful for medical device software developers involved in...
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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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