Loading skill
Install any skill in seconds. Free to start, no credit card required.
Get Started Free →mkurman/iec-62304
IEC 62304 medical device software lifecycle framework. Risk classification, software safety classification (A/B/C), design control, verification, validation, and regulatory documentation for FDA/EU MDR submissions.
Passed 22 of 22 test cases with the skill, and 21 of 22 without it.
1 fixed21 passed either way0 still failing0 broke
Tokens, turns and time describe resource use, not a dollar price.
A test case the skill fixed. Same model, same prompt, with and without the skill.
An embedded software module monitors fluid pressure in an intravenous infusion pump and triggers an audible alarm when occlusion occurs, preventing non-serious delay in therapy. Some team members suggest Class A because it only emits sound, while others suggest Class C. Which IEC 62304 safety class is required?
| Checked | Without skill | With skill |
|---|---|---|
| Assigns Class B safety classification. | Missed | Passed |
The instructions your model reads when the skill loads.
IEC 62304 medical device software lifecycle framework. Software safety classification (Class A/B/C), design control, verification, validation, and regulatory documentation for FDA and EU MDR submissions.
- Software Development Plan
- Software Requirements Specification
- Software Architecture Document
- Software Detailed Design
- Software Unit Verification
- Software Integration Testing
- Software System Testing
- Software Release Notes
- Software Maintenance Plan
- Software Risk Management File
test cases passed, vs 21 / 22 without
More skills from the same source and nearby in the registry, with their headline benchmark lift.