Last modified: 18-NOV-2024 Software as a Medical Device (SaMD) products do not involve hardware or manufacturing but their documentation is still complicated and it can be difficult to know what is truly required for compliance. To help reduce the confusion, I created this SaMD Documentation Map which illustrates the formal documentation needed for a typical […]
SaMD Documentation Map Read More »
Re-entrant design controls provide a systematic and efficient way to manage upgrades to a medical device over the lifetime of the product, which is especially important for software-intensive, connected medical devices or capital equipment.
Re-Entrant Design Controls: Managing Medical Devices That Are Never Finished Read More »
New FDA cybersecurity guidance raises the bar due to the alarming increase in cyber attacks on hospitals and healthcare technology in recent years.
Getting Started with the New FDA Cybersecurity Guidance Read More »
Understanding and implementing the new FDA cybersecurity guidance. A seaworthy medical device, like a well-designed ship, requires security measures in its design, operation, and maintenance.
An Introduction to Medical Device Cybersecurity on the High Seas Read More »
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
Rules Are Changing for FDA Submissions for Software Read More »
The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
Documentation for Medical Device Software Read More »
Erik Heuer describes his experiences accelerating medical device software development by bridging the gap between regulatory compliance and modern software development methods: incorporating DevOps concepts, leveraging documentation automation, and establishing the two wheels for innovation vs. development and deployment.
Accelerating Value Delivery for Medical Device Software Read More »
SaMD, or Software as a Medical Device, is not just another mobile app. It is a new category of medical device that has particular regulatory considerations and is at the forefront of some of the most innovative new healthcare technology.
Best practices for medical device HW testing are not best for SW testing Medical device development teams often ask me for help with software V&V. Even though they have their hardware development under control, these teams keep encountering software testing problems and the corresponding compliance documentation. Frequently, it’s because their company’s quality system, explicitly or
Software Testing Is Not Hardware Testing Read More »
Embracing Change: Your Connected Medical Device is Never Finished Embracing change means setting up your organization, processes, and tools to efficiently manage changes during product development and after product launch. Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices Learn the nuts and bolts of how to integrate risk management into the overall product
Newsletter V. 2019 Issue 1 Read More »
