Adopt
Electronic Quality Management System (eQMS). Purpose-built for medical device companies — ISO 13485 ready out of the box. Provides e-signatures (21 CFR Part 11 compliant), CAPA, non-conformance records, training records, and controlled document workflows. Far less engineering effort than building approval workflows on top of Confluence or Notion.
Chosen over Confluence (requires custom plugins, not purpose-built), Veeva (enterprise pricing, overkill at this team size), and Greenlight Guru (viable alternative if Qualio pricing becomes an issue). See DEC-004.