Prepare ISO evidence for devices and laboratories.
Organizes medical-device and laboratory evidence into draft readiness reviews for authorized humans, using local structural checks rather than making compliance decisions.
When to use it
Use when organizing scope, controlled documents, implementation records, traceability, and readiness evidence for human review against a named standard.
Give it organizational evidence and a declared standard and assurance lane; it produces local evidence manifests and gap reports for authorized human review.
What you provide
Requires Python 3.11 or later; the bundled command-line checks use only the standard library.
This skill
arXiv
Looks up the associated paper