Understanding all of the types of software at a medical device company is crucial to knowing what is required for validating, documenting, and controlling each type
Understanding the Software Landscape Read More »
Here’s a secret about understanding medical device software documentation: don’t start with a checklist of documents! Instead, start by understanding the processes necessary for compliance and the activities in those processes.
Secrets to Medical Device Software Documentation Read More »
This SaMD Documentation Map illustrates the formal documentation needed for a typical Software as a Medical Device (SaMD) product. The map is a graphical representation of the interdependencies of the product documentation and what is needed for an FDA 510(k) submission.
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.
