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Regulatory & Quality RegTech

Turn UDI submissions into a repeatable operation.

Audit-defensible workflows for UDI Ops (Swissdamed / EUDAMED / FDA GUDID). Public artifacts for review; delivery packs shared privately.

Request readiness check Readiness checklist Talk to us
EU MDR / IVDR ISO 13485 ISO 14971 IMDRF UDI

General information only. Not legal advice. Private detail sharing available (private agreement / limited scope / selective sharing).

Clarity
done vs blocked
Traceability
audit narrative
Repeatability
handover‑ready
Confidentiality
shared privately
Core deliverables
UDI Ops
Swissdamed / EUDAMED / FDA (GUDID) readiness
Evidence Packs
Traceability + review gates
Quality Ops
Doc control + change control
Reporting
Clear status summaries
Built for real constraints: messy data, tight deadlines, and zero tolerance for invented facts.
Integrity
Public downloads include integrity manifests for verification.
Integrity manifest Checksums

Built for repeatability

A practical operating layer: single dataset, readiness gates, and audit‑friendly handover—

Submission Ops Operating Layer (overview)

How it works (high‑level view) →

Input Controlled dataset + scope
Normalize One canonical record
Validate Completeness + consistency
Package Upload‑ready exports
Evidence Versioned handover pack
Time-to-submission Target: fewer weeks lost to rework (project‑dependent).
Reject risk Target: prevent avoidable rejects via pre‑checks.
Audit narrative Target: “what changed, why, who approved” — explainable calmly.

Public materials remain kept at a high level. Detailed delivery packs are shared privately (limited detail sharing, selective sharing as needed).

Single source of truth

One controlled master dataset that can drive multiple authority‑specific outputs.

Multi‑target outputs

Current focus: EU EUDAMED + CH swissdamed. Roadmap mappings are scope‑.

Audit‑friendly by design

Integrity manifests, change logs, and handover packs that survive scrutiny.

Open knowledge center Browse resources

UDI implementation timelines

snapshot of planning defaults used in our Swissdamed/EUDAMED cockpit templates. Always verify against official sources.

Switzerland (swissdamed) — planning defaults

  • Post-incident planning deadline: 2026-07-01
  • Legacy planning deadline: 2026-12-31
  • New (CH placed-on-market): from 2026-07-01 onward

These dates are used as portfolio triage defaults in our roadmap templates (not a legal guarantee).

EU (EUDAMED) — planning defaults

  • Legacy EU planning deadline: 2026-11-28
  • New MDR/IVDR: class/module dependent (not pinned here)

Open full timelines UDI Ops Contact options

Last updated: 2025-12-20

Standards-informed delivery

FWL.ai is not an ISO 13485‑certified organization. Deliverables are aligned to ISO 13485 / ISO 14971 practices where applicable.

Solutions

Three tracks. Start with one pack, then scale into a full operating system.

UDI & Submission Ops

Operational submission capability: readiness gates, consistency checks, and auditable handoffs.

  • Readiness scan + gap list + plan
  • Repeatable execution + guide
  • private detail sharing pack for sensitive material

Audit‑Grade Evidence Packs

A repeatable structure for “what happened, when, by whom, and why it’s compliant”.

  • Evidence mapping + review gates
  • Versioned outputs + verification path
  • Stakeholder summaries (clear, short)

Quality Systems Automation

Reduce overhead in document control and change management with standardized workflows.

  • SOP templates + controlled revisions
  • Impact assessment bundles
  • Handover packs that survive teams
Our stance

We don’t ship “advice”. We ship deliverables that survive audits.

Proof

Public examples are anonymized and outcome‑focused. We publish the minimum needed for evaluation; implementation remains shared privately.

What you get

  • Clear acceptance criteria and sanity checks
  • Traceability that can be explained calmly
  • Documentation that survives handoffs

What you won’t get

  • Invented laws, deadlines, or “trust me” compliance
  • Vague claims without verification steps
  • Careless handling of private materials
Example output types
(structure-only)
v1.x
Readiness Report
Done vs blocked
Evidence Pack
Traceability + gates
Execution Guide
handover-ready
Release Notes
Versioned changes

Evidence snapshot

What a typical engagement produces:

Acceptance criteria
defined upfront
Review gate
pre‑submit
Handover pack
survives teams
Integrity manifest
verification

News

Short, updates. For current build and integrity artifacts, see Status.

All news

No news posted yet.

Contact

Direct

For sensitive material, request private detail sharing (private agreement / limited scope / selective sharing).

Message

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