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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review,...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf file contains all software and computer related warning letter excerpts posted on this site for the years listed. Some of the newest warning letters on the site may not be included since we only update this...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review,...
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Sherman Eagles of SoftwareCPR® provides the following summary of some key points from FDA’s webinar on their premarket cybersecurity guidance on October 29. In the webinar FDA noted that the Instructions for Use should include what cybersecurity controls are needed in the use environment, but stated that it is not sufficient for a device to...
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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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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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The latest ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided: Mars Code February 2014
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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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A 2003 computer science thesis done at the University of York entitled “The Safety of Software — Constructing and Assuring Arguments” is at the link provided. Software Safety Cases – PhD Thesis
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The pdf at the link provided contains slides from a presentation by Brian Pate providing an overview of the soon to be released “Agile Methods for Medical Device Software Development” Technical Information Report (TIR). These slides focus on the TIR. We have posted another slide set in our library with some training slides on SoftwareCPR...
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The article “Build and Validate Safety in Medical Device Software”, available on the Medical Electronics Design Website at http://www.medicalelectronicsdesign.com or at the link provided above, provides an overview of the challenges and approaches to preventing and detecting software faults that can lead to hazardous situations. The article provides an overview of some of the relevant...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf file contains all software and computer related warning letter excerpts included on this site. Some of the newest warning letters on the site may not be included since we only update this comprehensive document periodically. This...
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The pdf at the link provided is a reprint of an article in the November 2010 issue of the Jounal of Medical Device Regulation entitled “US Medical Device Software Regulation”. This article was authored by Sherman Eagles, and Alan Kusinitz, Partners at SoftwareCPR.  The article provides an overview of FDA regulations related software distributed in...
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The link provided is to a NASA website on software development, V&V, quality and safety assurance. There are links to many software checklists that may relevant or a starting point for tailoring for medical device software. There is also a link to the 1997 NASA software safety standard from their website. NASA Software Assurance Website
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At the link provided is a paper issued in April 2008 by the Australian Department of Defense entitled: “Dependability of Software in Airborne Mission Systems”. It contains a useful list and description of software related standards outside the medical device industry that may be helpful in medical device software development and risk management. AUS SW...
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The Carnegie Mellon Software Engineering Institute continued work on safety assurance cases for medical devices by publishing a paper entitled “Towards an Assurance Case Practice for Medical Devices” doing an example case for an infusion pump. The full article is at the link provided. Although this is intended uses infusion pumps as an example it...
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For those using or interested in the SEI’s Capability Maturity Model, the link provided contains a white paper comparing IEC 62304 and the CMMi. This white paper was prepared by David Walker, a consultant that is a licensed SEI partner. It is published here with his permission. 62304-CMMi-comparison-DWalker092909
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The Carnegie Mellon Software Engineering Institute performs a number of research projects each year. Their december report on these projects is at the link provided. One of the projects was on safety cases for medical devices. Sherman Eagles of SoftwareCPR and Paul Jones of FDA participated in this project.TECHNICAL REPORT CMU/SEI-2008-TR-025 ESC-TR-2008-025 SEI assurance case...
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This topic contains several of the slide sets for presentations posted on the website. These include ONLY SOME of the FDA staff presentations as well as SoftwareCPR presentations. Others are available in the library section of the website.
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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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This topic contains selected partial document and procedure training templates as well assorted validation tips for validation of manufacturing and quality system software. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access....
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The pdf at the link provided is a reprint of an article entitled An Introduction to IEC 80001: Aiming for Patient Safety in the Networked Healthcare Environment” authored by Sherman Eagles, Partner at SoftwareCPR. This is reprinted with permission from the Association for the Advancement of Medical Instrumentation (AAMI), www.aami.org. The article first appeared 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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This is a list of ONLY SOME of the most popular software related articles and white papers on our website; additional ones can be found be searching our library. All reprints not copyrighted by SoftwareCPR are provided with permissions of the authors or publishers unless they are government issued public information. Please respect the copyrights....
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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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Dr. Nancy Leveson of MIT indicated that there are some new papers involving a demonstration of STAMP (and STPA) being used for safety-driven design of a new JPL mission to Europa including a very complete example. A JPL modeling language was incorporated (JPL was funding the work), but had little to do with the final...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Crimson Life Sciences which performs language translations for labeling and user interfaces was assessed by Underwriters Laboratory for conformance with the ISO 14971 Medical Device Risk Management standard. The summary of the audit results is available at this link...
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The link provided is a pdf of slides on validation of design tools presented by Carl Wyrwa of Beckman at the November 2005 ADVAMED FDA Conference. These are provided with his permission. Validation Of Design Tools Presentation Carl Wyrwa 03Nov2005 V9
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The link provided is a pdf of slides on software maintenance presented by Carl Wyrwa of Beckman at the November 2005 ADVAMED FDA Conference. These are provided with his permission. Software Maintenance Presentation Carl Wyrwa 03Nov2005 V9
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The pdf at the link provided is a reprint of an article entitled “Understanding CAPA Requirements in a Software Context” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal published in the Spring of 2004. AAMI – AKusinitz CAPA – article 0504
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The pdf at the link provided is a reprint of an article entitled “Software Test Coverage” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal and published in the Spring of 2003. AAMI-BIT-Software-Test-Coverage Article
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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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“Lessons from 342 Medical Device Failures” by Dolores R. Wallace and D. Richard Kuhn of NIST examines software related recalls for medical devices and their possible causes and preventive measures. IEEE-NIH_CBMS_Safety_Model-13
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The link above provides the slides and notes of a presentation made by David Manalan reqarding FDA’s Quality System Inspection Technique. David is an associate of SoftwareCPR and you can reach him at DManalan@softwarecpr.com or 978-266-1220. BOSCON manalan QSIT
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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 Medical Device and Diagnositc Industry periodical occassionally prints software articles oriented to Medical Device Manufacturers. To see their index of these articles by year, view the following link: MDDI Software Articles
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Published November 1999 in “Pharmaceutical Tecnology” was the the article “Using New Techniques for Reducing System Validation Time and Cost”. This article described an approach used in an Eli Lilly drug plant for validation of PLCs and an Intellution system where many similar but slightly different programs and pieces of manufacturing equipment were used. Its...
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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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“A Software Development Process Model for Artificial Neural Networks in Critical Applications” by David M. Rodvold Colorado Technical University and Xaim Inc.presented at the International Joint Conference on Neural Networks (IJCNN’99). Washington D.C. July 1999. In this paper Mr. Rodvold addresses the challenges of using neural networks in critical applications and describes an approach to...
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“Capability Maturity Mode Implementation and Risks” byTracey Briscoe of Quality Systems and Software (maker of the DOORS requirements management tool).This white paper provides a concise overview of the CMM and some common issues regarding its value, costs, and implementation approach. Quality Systems and Software has a variety of white papers and courses offered on its...
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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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