Agent skill · alirezarezvani
medical-device-software
Use for any question about the software inside a medical device, SaMD or regulated health app - which IEC 62304 safety class (A/B/C) it is and how much process and documentation that class needs, what to record about open-source or third-party libraries (SOUP, SBOM), trace matrix and release testing, IEC 81001-5-1 security, or the FDA documentation level and 524B cyber-device duties. Checks the user's files with four scripts that cite the clause.
What it needs
About 4k tokens when loaded.
What this skill does
Medical Device Software Portability: 4 stdlib scripts, no network. Fill CSVs, run, keep the output with the software file. Not a conformity assessment. IEC 62304 is paywalled: clause markers here come from two agreeing secondary sources (🟡) and your licensed copy prevails. A notified body or FDA reviewer can read a borderline call differently. Software files fail review in the same places: a class claimed lower than the harm allows, an "external" risk control that lives in the same software system, a SOUP list with "latest" as the version and no anomaly review, a trace matrix with risk controls nobody tested, and security treated as an afterthought. Three classifications get confused, and they use different inputs: Question Decided by Assessed --- --- --- IEC 62304 class A/B/C (which activities) worst-case harm, clause 4.3 + A1 Fig. 3 after risk controls external to the software system FDA Basic / Enhanced (what you submit) probable risk of death or serious injury before any risk controls FD&C Act 524B cyber device software + any internet-capable path (USB counts) not risk-based Workflow Class first: steps 2 to 4 take the class from step 1. --template prints an empty input; lifecyclegapcheck.py --list --class X prints the required ids. The gates block on (exit 4) 1. A claimed class below what the harm allows, or an item below its system without a segregation rationale — 62304 4.3. 2. An external risk control used to lower the class that is not itself verified — 62304 4.3 (A1). 3. A required activity NOT MET, or NA where the clause is not conditional — the class table (A1 Table A.1). 4. A SOUP item with no exact version (8.1.2), no stated requirements (5.3.3/5.3.4) or no anomaly-list review (7.1.3) for class B/C, or past end of support with no plan. 5. A class B/C risk control with no hazard or no passing test (7.3.1, 7.3.3); with --release, any untested requirement or open failed result without an anomaly record (5.7, 5.8). 6. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/medical-device-software--eeb9d3