IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part 1
The IEC-62304 Software Lifecycle Standard requires a lot of self-reflection to scrutinize and document your development processes. There is an endless pursuit of perfection when it comes to heavily regulated […]
Whitepaper: IEC 62304
Principles and Best Practices for Medical Device Firmware Development About the IEC 62304 Whitepaper Medical device software development is governed by IEC 62304, which mandates rigorous processes for development, testing, […]
On-Demand Webinar: Medical Development is Broken
Software complexity increases at a rate of 4x per decade. Productivity rises at 1.5x. This shortcoming is being felt by medical device OEMs balancing demand for new features, safety regulations […]
Accelerating Medical Device Development
Accelerate your medical devices’ embedded software development using cultural, process, and tool changes such as an embedded CI pipeline.
How Much is that Medical Device Going to Cost?
Why are medical devices so expensive? The answer lies in the development process. While creating a basic prototype can be relatively quick and affordable, transforming that concept into a regulated […]
Software Bill of Material (SBOM) for Medical Devices
Software Bill of Material (SBOM) for Medical Devices Modern devices are becoming increasingly more complex. Higher user expectations for product features and connectivity have developers looking […]
Medical Device Documentation
If you’ve ever built a medical device, you’ll know how much documentation is required. The amount of documentation required by regulatory bodies like the FDA can intimidate even the most […]
Medical Devices with Machine Learning?
This guest post is a collaboration with our friends at Edge Impulse. Edge Impulse shares D5’s passion and vision for modernizing embedded solutions by empowering developers to create and optimize products via embedded development and machine learning.
Start with the Process, Finish with the Work
Start with the process, Finish with the work To obtain regulatory approval for medical device software, you’ll need to comply with the IEC-62304 Medical Device Software Lifecycle standard. This standard […]
IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part II
Part I provides some background to IEC-62304. Part II provides a slightly more in-depth look at some of the specifics. The IEC 62304 Medical Device Software – Software Lifecycle Processes […]
IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part 1
IEC-62304 Software Lifecycle requires a lot of self-reflection to scrutinize and document your development processes. There is an endless pursuit of perfection when it comes to heavily regulated industries. How […]