Connected modules over one regulatory knowledge graph.

Gap Analysis: upload and configuration against EU MDR 2017/745 Annex II.

Clause-linked findings, not a wall of text.

• Checks your technical file against MDR Annex II obligations and grades every gap by severity, each finding linked to its governing clause.
• Remediation patches are preview-then-apply: see the proposed change, then write it as a new reviewable revision — never an overwrite.
• Findings stay current automatically: unacceptable residual risks, superseded standards, and overdue deadlines raise gap findings on their own.

Document drafting: MDR document-type configuration for a demo device family.

Evidence-grounded drafting for 20+ Annex II document types.

• CER Builder with an MDCG 2022-2 equivalence panel and a deterministic PubMed literature pipeline — methodology log generated automatically.
• Drafter output marks every unresolved item as a typed placeholder, split into critical items and suggestions — you always see what's missing before sign-off.
• Every AI-drafted assertion is validated against the knowledge graph before you see it: node must exist, confidence threshold met, evidence present in the document.

GSPR clause conformity and required document-type tracking for a demo device.

23 GSPR rows, each mapped to real evidence.

• The full MDR Annex I GSPR checklist is seeded per device from the knowledge graph — conformity status and evidence mapping in one view.
• Evidence items link directly to document sections and GSPR rows, with citation metadata (DOI/PMID) and a one-click Vancouver-style bibliography.
• Every vault item records its ingestion lineage and the export manifest is SHA-256 hashed — provenance you can show an auditor.

How Sentinel turns a guidance update into an acknowledged, audited event.

When MDCG guidance changes, you find out — and it's on the record.

• Monitors 40+ MDCG guidance documents for updates, with affected-device impact written to an immutable audit row at detection time.
• Your review of each change is recorded permanently — a GAMP 5 acknowledgment trail showing the human saw it and acted.
• Superseded harmonized standards cited in your file automatically raise gap findings, so guidance drift never goes unnoticed.

Regulatory hub: submission pipeline and deadline alerts for demo devices.

Know you're ready before the formal clock starts.

• Four parallel checks before export — cross-document consistency, completeness, PRRC sign-off queue, and critical gaps — each with a traffic light.
• Exports are anchored by a cryptographic snapshot: a SHA-256-hashed manifest of the technical file, append-only by design.
• PSUR, CER, and PMCF deadlines are computed per device and market, with escalating alerts your team can't accidentally silence.