Nice overview article of Grad CAM (Gradient-weighted Class Activation Map) which can be used to generate “heatmaps” highlighting the relevant regions of an image that contributed to the model design.  This can be useful in documenting the “explainability” portion of the model documentation that one will likely need for a regulatory submission.  Read More

An excellent tool in your arsenal for ensuring software quality is to establish software design patterns. Software design patterns can help reduce the insertion of software defects and also facilitates finding software defects during development. One to consider is GRASP software design guidelines that help to create consistency with software class responsibility. GRASP is acronym...Read More

Struggling with cybersecurity planning, execution, and postmarket surveillance? Asking yourself, “what does FDA expect?  If it is any consolation, most medical device manufacturers are right there with you! But we have noticed that many struggles likely could have been avoided. The good news is that cybersecurity is on your radar – likely that is why...Read More

… declares the table of contents for an article, subtitled Software problems are responsible for 20 recalls a month in IEEE’s Spectrum magazine December 2025 issue (the article is available without an IEEE account: https://spectrum.ieee.org/medical-device-recalls) The article includes several summary charts about U.S. Food and Drug Administration (FDA) medical device recall data back to 2005,...Read More

Why Software Keeps Failing is the title of the editor’s page for IEEE’s Spectrum December 2025 issue. The answer to “why software keeps failing”? Lessons are learned but not applied. From the editor: In 2005’s “Why Software Fails,” in IEEE Spectrum, a seminal article documenting the causes behind large-scale software failures, Charette noted, “The biggest...Read More

You may have experienced the concept of diffusion of responsibility – when members of a group feel less personal obligation to perform an activity or task, assuming “someone else will handle it,” leading to inaction, delays, or reduced accountability. This can occur when the quality management system either poorly defines responsibility or defines responsibility to...Read More

We understand the tension. You get it … we all want to be process focused. Create and maintain a good process, and good outputs will come forth. But you may be the one that faces the auditor or faces the inspector. They ask for evidence that the process was performed. You think, “life would be...Read More

The international standard, ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, provides the framework of the set of interrelated processes that work to ensure product quality.  This international standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be...Read More

Updated: Final guidance released August 25, 2025. View the document: 2025-08-Guidance-Predetermined-Change-Control-AI The US FDA has a continuous challenge trying to ensure that regulations keep up with advancements in technology.  As with any new technology, manufacturers try and make the existing regulations applicable, while FDA assesses whether or not existing regulations are appropriate for the new technology. ...Read More

Design Approval Requirements and Signatures: Navigating 21 CFR 820 and ISO 13485 Medical device manufacturers often struggle with a fundamental question: What signature requirements apply to design input and design output approvals? Understanding how 21 CFR 820 Design Controls and ISO 13485 address design approvals is essential for achieving both compliance and operational efficiency. This...Read More