Menu

Platform

AI Auditor

Clause-mapped compliance audits against IEC 62304 and your QMS, with audit-ready evidence.

Each finding maps to specific IEC 62304 and ISO 13485 clauses. The analysis explains the root cause, suggests a rectification plan, and tracks its implementation. AI Auditor keeps the audit trail audit-ready.

What it is for

  • Stay audit-ready year-round, with corrective actions tracked to closure.
  • Run gap analyses that strengthen your software development lifecycle and Good Machine Learning Practice.

Workflow

  1. 1

    Upload the SDLC file

    PDF, DOCX, Markdown, or CSV.

  2. 2

    Scan against the standards

    The audit runs against IEC 62304 and ISO 13485.

  3. 3

    Read the finding

    Each finding maps to specific clauses, shows the document evidence beside the requirement, and explains the root cause. Severity is major or minor, with a confidence indication.

  4. 4

    Quality Engineer confirms it

    A quality engineer reviewer confirms non-conformances. The human stays in the loop.

  5. 5

    The trail keeps building

    The audit trail becomes end-to-end traceable. QMS rectification becomes proactive.

  6. 6

    Export the report

    Reports cover scope, summary, findings, clauses, and recommended deliverables. They can be edited and exported to DOCX.