Medical QMS
ISO13485 Certified System
Medical Device QMS
Medical Device Quality Management System • Global Compliance
FDA Registered • CE Certified • OEM/ODM Manufacturing
Standard Scope
ISO 13485 System Introduction
ISO 13485:2016 certifies Furuize's medical device QMS for reusable menstrual cups and discs — covering molding, finishing, packaging, and OEM labeling with annual surveillance and three-year recertification.
- • Risk-based process controls aligned with EU MDR and FDA QSR
- • Design controls, supplier management, and batch traceability
- • Cup/disc molding, cleanroom production, and lot release testing
- • Governs production-process, QC, and testing-lab documentation
- • Backbone for FDA, CE, and SGS compliance file assembly
Process Architecture
Quality Management Processes
The Furuize QMS maps ISO clauses to named processes with owners, inputs, outputs, and performance indicators — each process interacts through defined interfaces so supplier changes automatically trigger reviews across production, regulatory, and testing.
QMS Process Flow
How ISO clauses map to named processes
Design & Development Control
OEM projects receive design inputs (capacity, hardness, color, packaging), risk analysis per ISO 14971, verification plans, and design transfer checklists before FAI. Customer-owned artwork revisions pass change control with impact assessment on labeling and biological evaluation status.
Supplier & Purchasing Management
LSR, pigment, and packaging vendors qualify through audit scores, COA review, and incoming inspection history. Approved supplier lists tier vendors by criticality; demotion occurs after repeated IQC failures without acceptable CAPA.
Production & Service Provision
Controlled SOPs govern molding, trimming, cleanroom conduct, and kitting. Travelers record material lots, mold IDs, and environmental OK flags. Nonconforming product control prevents silent commingling of hold inventory with release stock.
Monitoring, Measurement & Analysis
KPI dashboards track first-pass yield, complaint rate per million units, calibration overdue items, and on-time CAPA closure. Data feeds management review quarterly with trend charts, not single-point snapshots.
Regulatory & Post-Market Interface
Regulatory affairs maintains technical file indexes for EU, US, and UK pathways. Complaint records route to OEM within SLA; serious incidents escalate through agreed MDR/vigilance evaluation workflows without assuming importer responsibility.
Audit Cycle
Internal Audit & Continuous Improvement
Internal audit program
Independence-qualified auditors sample travelers, training records, and shop-floor behavior against SOP — findings tracked in CAPA with mandatory due dates.
Management review
Quarterly reviews examine audit results, complaints, supplier performance, and KPI trends — decisions minuted with action owners and verification dates.
CAPA & improvement projects
Corrective action addresses root cause; preventive action addresses recurrence risk. Effectiveness checks confirm fixes still work six months after closure.
Employee suggestion loop
Operators submit improvement cards on mold changeover waste and label misfeed near-misses — accepted suggestions enter the kaizen backlog with performance credit.
Controlled Knowledge
Documentation & Record Control
Document control rules
Unique document IDs with version suffix, electronic masters on secured drives, and change requests requiring impact assessment across affected SKUs.
Record retention matrix
Device history records retained seven years post-shipment; IQC/OQC data linked to silicone lot and mold shot count.
DMR & DHR pairing
Device Master Record indexes mold drawings, material specs, and label approvals; Device History Record proves each batch was built to that DMR.
OEM due diligence packs
Sanitized DMR excerpts and sample DHR packages available during vendor qualification — enough to validate structure without exposing unrelated client geometry.
Partner Confidence
OEM Reliability Advantages
Faster vendor qualification
Current ISO 13485 certificate with menstrual cup scope collapses weeks of pharmacy and marketplace due-diligence back-and-forth.
Multi-market file reuse
EU MDR, UKCA, and FDA dossiers draw from the same design files, risk analyses, and test reports maintained under ISO document control.
Batch-to-batch consistency
Travelers, SPC charts, and golden-sample programs cap rim-diameter drift across reorders — investigation triggers before customers notice field issues.
Long-term partnership stability
Surveillance audits pressure-test the system yearly; scope continuity protects marketplace rankings tied to a stable supply base.
Certification portfolio
ISO sits alongside FDA registration and SGS test evidence — each addressing different buyer questions.
ISO 13485 Certification FAQ
Is Furuize ISO 13485 certified for menstrual cups?
Yes — QMS scope covers manufacture of reusable menstrual cups and discs from medical-grade LSR, including tooling and OEM packaging assembly on site.
What does ISO 13485 mean for OEM buyers?
Documented design controls, supplier management, production validation, and batch traceability — see QC system for operational detail.
Can you provide the certificate for vendor onboarding?
Scope certificate and audit summaries available on request via compliance inquiry for pharmacy and marketplace gates.
How does ISO 13485 relate to FDA and CE?
ISO is the factory QMS backbone; FDA registration and CE technical files address market-specific pathways.
Related Compliance & OEM Resources
Certifications & Testing
Manufacturing & Launch
ISO13485 Certified Manufacturing System
Build your menstrual cup brand with a fully compliant medical device manufacturer.