About Denovo Digital

## What this is Denovo Digital is the firm's living register of medical-device standards and the working commentary its consultants build around them. Each standard is summarized, each tracked clause is annotated in the firm's voice, and each editorial piece situates a change against the broader regulatory landscape. ## What this is not It is not a substitute for the source standards. Quotation is limited by policy and enforced at build time. For normative text, follow the “view source” link from any clause page. It is not regulatory advice. The firm's interpretations are working positions, not legal opinions. ## Methodology - **Inputs.** Issuing-body publications (FDA, ISO, IEC, IMDRF, EU), guidance feeds, and the firm's internal practice notes. - **Drafting.** New standards and amendments are drafted by an agentic ingestion pipeline overnight; senior consultants review and approve each draft via pull-request before it is published. - **Voice.** First-person plural, declarative, evidence-led. The editorial style guide governs. - **Versioning.** Every change is a Git commit. Every published page has an audit trail. ## Colophon Built with Jekyll. Served from Cloudflare Pages behind Cloudflare Access. Brand palette: cream, coral, sage, teal. Typography: Inter and JetBrains Mono.