Standards & References

This page lists public, non-private reference points that inform the “audit-grade” posture of FWL.ai deliverables. It is intentionally High-level: we do not publish claim language, implementation details, or client-specific work products.

How to read this

References below are provided for context and traceability. Applicability depends on jurisdiction, device scope, and project constraints. This site is not legal advice.

Regulations & official platforms

EU MDR — Regulation (EU) 2017/745 (Official Journal). EUR‑Lex ↗
EU IVDR — Regulation (EU) 2017/746 (Official Journal). EUR‑Lex ↗
EUDAMED portal (modules include Actor registration and UDI/Device registration). Portal ↗
European Commission: UDI/Device registration overview. EC page ↗
MDCG endorsed documents and other guidance (EU MDR/IVDR). EC index ↗
MDCG 2018-1 Rev.4 — Guidance on Basic UDI-DI and changes to UDI-DI (April 2021). PDF ↗
MDCG 2019-1 — Guiding principles for issuing entities policies on Basic UDI-DI (January 2019). PDF ↗
US FDA (eCFR): UDI labeling requirements (21 CFR 801 Subpart B) and UDI system (21 CFR 830). 21 CFR 801 ↗ 21 CFR 830 ↗

Core QMS, risk & usability standards

ISO 13485:2016 — Quality management systems for medical devices. ISO ↗
ISO 14971:2019 — Risk management for medical devices. ISO ↗
ISO/TR 24971:2020 — Guidance on applying ISO 14971. ISO ↗
IEC 62366-1:2015 — Usability engineering for medical devices (Human Factors Engineering). ISO/IEC ↗

Human factors & usability engineering

FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (2016). FDA page ↗ PDF ↗
IEC 62366-1 as the baseline process reference for use-related safety (see above).

Data integrity & audit-trail principles

MHRA: GxP Data Integrity Guidance and Definitions (Revision 1, March 2018). PDF ↗
UK GOV: Guidance on GxP data integrity (landing page and updates). gov.uk ↗
PIC/S: Guidance on Data Integrity (PE 009 series). PDF ↗

Global UDI harmonization

IMDRF: Unique Device Identification system (UDI system) Application Guide (IMDRF/UDI WG/N48 Final:2019). Landing ↗ PDF ↗
European Commission: UDI/Device registration in EUDAMED (see above).

FDA UDI & GUDID (official)

FDA: Unique Device Identification System (UDI System). FDA page ↗
FDA: Global Unique Device Identification Database (GUDID). FDA page ↗
FDA: UDI rule, guidances, training, and technical documents (UDI & GUDID). FDA index ↗
FDA: Submit data to GUDID (web app & HL7 SPL). FDA page ↗
FDA: Prepare for GUDID (checklist). FDA page ↗
FDA: Request a GUDID account. FDA page ↗
AccessGUDID (public search + downloads). AccessGUDID ↗ API ↗

Note: standards and regulations evolve. This list is maintained to support traceability of public claims, not to prescribe a one-size-fits-all compliance strategy.

Last updated: 2026-01-01