Make Issue Spec

Create, read, edit, and manipulate Word documents (.docx files) with formatting, tables, images, and tracked changes.

Create, read, edit, and convert PowerPoint (.pptx) files with design guidance and visual QA workflows.

Track code changes with structured JSON records, an enforced state machine, and a session handoff format for AI continuity.

Guides users through a structured three-stage workflow for co-authoring documentation, proposals, technical specs, and similar documents.

Read, create, and review PDF files with visual rendering checks using Poppler, reportlab, pdfplumber, and pypdf.

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.