“Codethink today announced the publication of its baseline Safety Assessment report for Codethink Trustable Reproducible Linux (CTRL OS). exida’s assessment validates Codethink’s safety argument for use of CTRL OS in safety-critical and mixed-criticality systems up to SIL 3 / ASIL D, and independently confirms that Codethink’s approach satisfies the expectations of both IEC 61508 and...Read More

Refreshing to see such a clearly articulated discussion of #software #design. A good reminder that #softwarequality is “designed-in,” not “tested-in.” Kudos @flightaware https://t.co/CmxySpg6VH — @softwarecpr (@softwarecpr) March 7, 2025 Can #medicaldevice companies rediscover the inherent #quality benefit one gains from well thought out, peer-reviewed software design? This is just one of the topics we will...Read More

Another insight from our software risk management series on software risk analysis considering general microprocessor failures and concerns that should be considered by the software development team. Enjoy!   Fourth post on software risk analysis. When we consider general #microprocessor failures and concerns, one generally starts with the processor operating core working outward. For example,...Read More

Are software engineers a commodity that managers can simply plug-n-play expecting a similar outcome? From X … Are software engineers a commodity that organizations can simply plug-n-play expecting a similar outcome? Unlike many other disciplines, software engineering allows a great deal of freedom within the design space. Two different software engineers can produce significantly… —...Read More

Software Risk Management Series: The expectations of US regulations and for IEC 62304 compliance for software can be overwhelming. Software hazards analysis and risk management is certainly one of the more difficult tasks for developing medical devices containing software. In this post we discuss FTA and FMEA/FMECA methods. How do these methods align with specific...Read More

Software Risk Management Series: The expectations of US regulations and for IEC 62304 compliance for software can be overwhelming. Software hazards analysis and risk management is certainly one of the more difficult tasks for developing medical devices containing software. Common questions: What activities should the development team perform? How do we capture the software analysis?...Read More

Started a series on software risk management on X in 2024 and plan to finish it out here in the first part of 2025. Look for more to come in this series! Follow this link for more detail in the X post … #iso14971 #riskmanagement must start VERY early in the #productrealization process. Even as...Read More

Improving medical device software development isn’t just about adding or modifying. The simplest approach is to NOT do things that don’t need doing. This is a key theme we cover in our training and consulting. “Faster, better, cheaper” is easier to attain when you do less and reduce complexity. The same applies to safety and...Read More

Learn about the Canadian regulatory framework from SoftwareCPR® partner, Ginny Kwan Gattinger, who will give a presentation at the RAPS Global Regulatory Strategy Conference in Baltimore, MD on March 7, 2024, at 10:30 am EST. The conference is being held at the Hilton Baltimore near the BWI Airport. Ginny will co-present with our affiliate, Karen...Read More

What does the US FDA expect in a premarket submission for description of the software design?  In the recent June 2023 Guidance for Industry and Food and Drug Administration Staff titled, “Content of Premarket Submissions for Device Software Functions,” the FDA gives the following guidance. For lower risk devices, the manufacturer is not required to...Read More

Software risk analysis requires consideration of both the development process itself and the runtime environment.Read More

The recent FDA guidance, Content of Premarket Submissions for Device Software Functions (June 14, 2023), points out that software design is a prospective activity and should not be done in an ad-hoc or last-minute approach.Read More

#software #capa … Should a #medicaldevices manufacturer treat potential software design issues any different than any other product #quality issue?Read More

FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions.  This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s Guidance for the Guidance for the Content of Premarket...Read More

(Ann R. Thryft. 11-16-22. Mddionline.com) A team made up of Sensoria Health, Foot Defender, and former Nike shoe designers came together to create a cloud-based patient monitoring boot for Diabetes patients. On the extreme, but very realistic side, this technology could help save patients from requiring an amputation if used correctly after ulcer surgery. The...Read More

Crisis Prevention and Recovery, LLC / SoftwareCPR, Tampa, FL USA – (November 22, 2022) “We are pleased to announce that our Partner and General Manager, Brian Pate, has been selected  for membership on the UL 1998 Standards Technical Panel for Software (STP), with oversight of UL 1998 standard, Software in Programmable Components.  Brian will provide stakeholder input to...Read More

Just a few thoughts on metrics … specifically software metric.  A software metric defines a standard way of measuring some attribute of the software development process or an attribute of a software component. A software metric allows us to compare and evaluate one process or component with another, and plan to improve quality of a...Read More

Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...Read More

When considering software process and software validation requirements for “product software” versus “tool software,” it can be very confusing and challenging.  We have created a job aid that can help facilitate the discussion of the differences between the two.  Product software runs as part of the product, whereas tool software is software running a tool...Read More

Background of the Medical Software Functions Exclusion Most of those in the industry do not question whether the FDA has the authority to regulate software that qualifies as a device. However, there are many intricacies in the definitions of the 21st Century Cures Act – which, in 2016, amended the definition of medical devices in...Read More

The Institute of Electrical and Electronics Engineers (IEEE) has approved a proposal to develop a standard for safety considerations in automated vehicle (AV) decision-making.  Purportedly, the “forthcoming IEEE standard will provide a useful tool to answer the question of what it means for an AV to drive safely,” according to the lead convener.  With technology...Read More

In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service –...Read More

Came across this website that has some very detailed “commandments” for software development at their company.  A surprisingly lengthy list of dos and don’ts related to coding, testing, designing, estimating, and managing the software lifecycle.  Does your company have anything written?  I often find that each company has some “lore” – some practices that characterize...Read More

In the July 2006 IEEE Computer Journal article: “The Power of 10: Rules for Developing Safety- Critical Code” by Gerard J. Holzmann of the NASA/JPL Laboratory for Reliable Software, the following 10 rules were listed: Restrict all code to very simple control flow constructs—do not use go to statements, set jump or long jump constructs,...Read More