Aivera reads new rules and your documents side by side, drafts the fix, and stops for a qualified person to approve it. Every answer has a source. Every decision has a signature.
Part 11 e-signatures · Source-linked evidence · Per-customer data isolation
Real audit log — every workflow start, gate decision, and signature in one filterable feed.
Why now
Since February 2, 2026, FDA inspects device makers against the QMSR, its quality rules built on ISO 13485. Internal audits and management reviews are now open to inspectors, so compliance has to be current every day — not reconstructed the week before.
Sources: FDA QMSR Final Rule (Federal Register); AdvaMed 2025 Global Medical Device Recall Index; industry estimates.
What it runs today
Sources on every claim, a qualified person ruling on every call, and a signed record you can hand to an inspector. Every release is tested against a fixed answer set.
QMSR · ISO 13485
Maps your SOPs to every QMSR and ISO 13485 clause. Aivera proposes covered, partial or gap with quoted evidence; a reviewer rules on each clause, and a re-run never overwrites a ruling.
ISO 13485 §5.6.2
Builds the review from your audit, CAPA, complaint and process records. Each of the 12 required inputs is marked present, thin or missing — never skipped — and every figure comes from a quoted record.
FDA 510(k) guidance Beta
For each design, supplier, labeling or software change: finds the affected documents, then walks FDA's 510(k) questions to a letter to file, a new 510(k), or an RA expert. No letter to file without a verified FDA quote at every step.
How it works
Aivera never has the final say. Nothing moves without a qualified person signing it, and the whole chain stays on the record.
A regulation you track changes, or you drop in an SOP, supplier agreement or design record.
Each finding links your document to the exact rule text it touches. Proposals stay unreviewed until a person rules.
The workflow pauses at a gate. Approve, edit or reject — with a Part 11 e-signature carrying printed name and meaning.
Every source, draft, decision and signature lands in one filterable feed. Replay it months later. Hand it to an inspector.
Why Aivera
Our edge isn't the model. It's the approval workflow and the audit trail that regulated buyers need — and we plug into the quality system you already run instead of replacing it.
Veeva, Greenlight Guru and MasterControl store the record, but rule changes still get mapped to your SOPs by hand. Aivera does the mapping and hands them the signed result.
A chatbot can't prove which source it used or who approved the output. For an FDA-regulated record, that's a non-starter — no matter how good the writing is.
Human approval isn't an optional setting. Every gate decision carries a Part 11 e-signature with printed name and meaning, captured at the moment of the call.
Every release runs against golden sets with zero-tolerance checks, so you can tell an inspector how this version behaves — not how the model felt that day.
Audit-grade by default
Built for the inspection you haven't been scheduled for yet.
Send us a handful of SOPs and we'll run a mock QMSR audit in a sandbox — clause by clause, with the evidence quoted and the gaps named. No cost, no commitment.
Or email hello@aivera.us directly.