Results for “quality-manual”

Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2 for HealthTech and MedTech companies.

Validate SKILL.md files against a quality rubric, scoring schema and instruction structure out of 100 and reporting a pass/fail verdict with specific fixes.

Build and review high-quality technical documentation, including agent instruction files and contributor-governance files, with support for audits, multilingual parity, and sub-agent orchestration.

Provides ISO 13485 internal audit methodology for medical device quality management systems, covering audit planning, execution, nonconformity classification, and external audit preparation.