NASA’s Venus Flyby In 1962 NASA failed its first attempt to explore Venus in a whopping $18.5m software bug. A loss that today would be around $150m. What happened? The Mariner 1 The Mariner 1 mission, NASA’s first attempt to explore Venus, was lost due to a software glitch caused by a typographical error inContinue reading “An Expensive Software Bug”
Author Archives: C. Austin
A Helpful MedDev Expert
Unveiling the Future of Customized AI: My Experience with OpenAI’s Latest Innovation In the ever-evolving world of artificial intelligence, OpenAI has once again raised the bar, introducing a groundbreaking way to personalize AI chatbots. Imagine having a chatbot tailored to be an expert in your chosen field or topic. With the latest advancements in ChatGPT,Continue reading “A Helpful MedDev Expert”
MedTech News
October 2023 Recent medical device news highlights related to Class III implantable medical devices in the areas of cardiac rhythm management and diabetes treatment. Always ensure to follow up on the provided links for detailed information. I found MITs implantable device with pancreatic islet cells and an oxygen factory fascinating and scary. I would haveContinue reading “MedTech News”
The FBI Vault
Have fun reading historical FBI investigation files on interesting topics that extend from unexplained phenomena like Roswell to Mobsters like Al Capone. https://vault.fbi.gov/
I’ve gone tubing…
Now on YouTube. Check out my channel. https://www.youtube.com/@CAInsightandMore
Bill S. 2103
AI Image Animation
Embracing the Shift: FDA’s New Risk-Based Approach to Non-Device Software Assurance in Medical Device Industry
The Food and Drug Administration (FDA) has recently released a draft guidance that signals a significant shift in their approach to software used in the production and quality systems of medical devices. This new guidance, titled “Computer Software Assurance for Production and Quality System Software”, emphasizes a risk-based, lifecycle approach to software assurance, moving awayContinue reading “Embracing the Shift: FDA’s New Risk-Based Approach to Non-Device Software Assurance in Medical Device Industry”
Understanding the FDA’s PCCP for Software Changes
In the rapidly evolving world of medical technology, the ability to swiftly and efficiently update software is crucial. The FDAs innovative Predetermined Change Control Plan (PCCP) approach is set to revolutionize the process of making post-market software modifications to medical devices, particularly those incorporating artificial intelligence/machine learning (AI/ML) technologies. Traditional Approach vs The PCCP ApproachContinue reading “Understanding the FDA’s PCCP for Software Changes”
Revolutionizing Medical Device Software: A Look at the New FDA Guidance
On June 14, 2023 the U.S. Food and Drug Administration (FDA) finalized a new guidance document (Content of Premarket Submissions for Device Software Functions) that could be the shift in policy that marks a significant step towards modernizing and streamlining the regulatory process for medical device software, potentially leading to faster innovation and improved patientContinue reading “Revolutionizing Medical Device Software: A Look at the New FDA Guidance”
C. Austin Insight 