Compliance Governance & Scope Boundary
Core Principle:
Regulatory validity is product-specific (mapped via GMDN/UMDNS codes), not blanket-certified.
Manufacturing Assurance:
Operated under ISO 13485:2016 certified QMS.
RA/QA Transparency:
Backed by direct engineering/regulatory file review to eliminate pre-production compliance gaps.
Quality Management System (QMS) & Audit Readiness
Foundation: Documented ISO 13485: 2016 core with traceable CAPA and supplier control loops.
Buyer Qualification Package Available:
QMS Certificate & Notified Body / Registrar scope verification
Manufacturing site master file summary & cleanroom/assembly line specs
Incoming-to-final inspection SOPs & calibration logs
CAPA closure metrics and historical audit readiness summary
Product-Specific Regulatory & Technical Files
Documentation Dossier Match:
Declaration of Conformity (DoC) linked to specific SKU/model
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Technical Documentation (TD) / Essential Requirements / General Safety and Performance Requirements (GSPR) summaries
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ISO/IEC 17025 accredited test reports ( biocompatibility, physical performance, shelf-life aging)
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Material Safety / biocompatibility declarations (ISO 10993 framework where applicable)
CE & European Market (MDR/IVDR Alignment) Boundary
Conformity Route:
Assessed per Annex/route classification (e.g., self-declaration for Class I low risk vs. NB involvement for measuring/sterile Class I or Class IIa+).
Support Provided:
GMDN mapping, technical file gap check, and pre-market clinical/performance evaluation alignment support for European authorized reps or importers.
FDA & U.S. Market Requirements
Regulatory Posture: Clear distinction between manufacturer establishment registration, device listing, and 510(k)/exempt status.
Buyer Review Package:
Establishment registration verification details
UDI (Unique Device Identification) readiness and barcode grading standards
Labeling compliance check against 21 CFR part 801
Import-ready documentation (Commercial invoice/packing list harmonization with device description)
Verification, Testing & Inspection Protocol
Pre-Production Alignment: Before cutting batch orders, we lock down:
- AQL sampling level (e.g., ISO 2859-1 general inspection level II)
- Test methods, acceptance criteria, and third-party lab option protocols
- Functional, dimensional, and visual defect classifications (Critical, Major, Minor)
Material & Traceability Control (UDI / Lot-Level)
Traceability Chain:
Raw material lot ➔ Production line shift/operator log ➔ Assembly/packaging count ➔ Finished goods UDI/batch barcode.
Custom Requirements:
Serialization or UDIcarrier integration defined and signed-off prior to master carton printing.
Material & Traceability Control (UDI / Lot-Level)
Submit Diagnostic Inquiry (Parameters below)
24–48h Gap Analysis: Cross-check GMDN, ISO 13485 scope match, and test report availability.
Lock Compliance Sign-off: Freeze label artwork, UDI format, and AQL standard.
Volume Production & Lot Dossier Delivery.
Get a Pre-Production Compliance Gap Analysis
Product Name / Model:
GMDN / Intended Use:
Destination Market / Country:
Target Regulatory Standard (e.g., CE MDR Class I, FDA exempt/510k):
Expected Order Quantity (MOQ/Trial/Volume):
Documentation Required (Checklist or Custom Audit Dossier):
Existing Product Specification / Drawing Link: