What Do You Need To Do? Looking At IEC 62304 And Other Docs
Dr. Oliver Eidel
What Do You Need To Do? Looking At IEC 62304 And Other Docs
Next, let’s look at what the hell “medical device documentation” actually includes. I’ll walk you through our templates and give you some examples of how you would fill them out.
Things I cover:
- ISO 13485 templates for quality management system documentation
- IEC 62304 templates for software documentation
- ISO 14971 templates for risk management documentation
- IEC 62366 templates for usability documentation
- Clinical evaluation templates for, you guessed it, clinical evaluation documentation
