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FDA released a draft guidance document, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” on January 7, 2025. The document provides recommendations on the contents of submissions (be it a 510(k), De Novo, PMA, HDE, or BLA) to FDA for devices that include AI-enabled device software functions and provides recommendations for the...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

Read on for some helpful questions to ask (essentially a “How-To” Guide for GUDID) when following GUDID, based on the recent FDA guidance document, “Global Unique Device Identification Database (GUDID).”   “How-To” Guide for GUDID What does the UDI rule require labelers to do? Include a unique device identifier (UDI) on device labels and packages...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

(Tampa, FL, October 9, 2024) – Crisis Prevention and Recovery, LLC is taking proactive steps to minimize impact to our clients from the landfall of Hurricane Milton in Southwest Florida.  With our corporate office in Tampa, Florida, there is a possibility of short term loss of electrical power and/or internet in the next 24 to...Read More

Use of master files can be a convenient and strategic method for SaMD manufacturers or software suppliers to provide information necessary for a US regulatory submission without disclosing confidential and/or proprietary trade secrets to business partners. For example, a software supplier of a cloud library providing medical device functionality could submit a master file to...Read More