Fda

iso-13485-certification helps medical device teams prepare ISO 13485:2016 certification documentation. Use it for gap analysis, Quality Manual drafting, required procedures, work instructions, Medical Device File content, and audit prep. It is especially useful for technical writing and certification-ready QMS documentation.

clinical-reports is a structured writing skill for clinical case reports, diagnostic reports, clinical trial reports, and patient documentation. It supports CARE, ICH-E3, HIPAA, FDA, and ICH-GCP workflows, with clear templates and guidance for accurate, de-identified, publication-ready clinical writing.