Quality Compliance &
Global Certifications
Your hemostasis products are used in the most extreme environments and most critical moments — quality cannot have any compromise. Ruten Medical's quality management system is rigorously designed to comprehensively exceed ISO 13485, FDA, CE, and GMP global medical device regulatory requirements. 100% batch traceability.
5+
International Certifications
5,000+
Annual Test Batches
6+
Compliance Standards
International Certification Matrix
5 international compliance certifications supporting market access in 20+ countries.
ISO 13485:2016
TUV SUD CertifiedInternational standard for medical device quality management systems. Covers the full lifecycle of product design, development, production, installation, and service quality assurance.
FDA Registration
Facility Registration & Device ListingU.S. FDA facility registration and medical device listing. FDA 510(k) pre-market notification preparation completed.
CE Marking
EU MDR ComplianceCompliant with EU Medical Device Regulation (EU MDR 2017/745). Covers 30+ countries and regions.
GMP Compliance
Aseptic Production Standards4,000 sqm ISO Class 7 cleanroom facility, covering weighing, filling, inner packaging, and full-chain aseptic sterilization controls.
TCCC Recommended
Tactical Medical CommitteeProduct performance meets hemostatic dressing standards recommended by the Committee on Tactical Combat Casualty Care (CoTCCC).
ISO 10993
Full Biocompatibility PassedPassed the full ISO 10993 biocompatibility test series, covering cytotoxicity, skin sensitization, intracutaneous reactivity, systemic toxicity, and other key safety endpoints.
Sterilization Validation & Testing
Ruten Medical operates a 200 sqm independent quality laboratory equipped with a full suite of hemostatic material performance testing equipment. 5,000+ annual test batches completed.
Sterilization Validation
Validated ethylene oxide (EO) sterilization cycles with dual biological and chemical indicator monitoring in every chamber. SAL reaches 10^-6.
Biocompatibility Testing
Full ISO 10993 test series passed, covering cytotoxicity, skin sensitization, intracutaneous reactivity, systemic toxicity, and other key safety endpoints.
Accelerated Aging & Stability Studies
Constant temperature/humidity chambers simulate up to 5-year shelf life, verifying product performance under extreme storage conditions.
In Vitro Coagulation Kinetics Testing
Fully automated coagulation analyzer monitors clotting time, coagulation rate, and maximum clot strength in real time.
200 sqm Independent QC Center
Equipped with 30+ professional testing instruments, completing 5,000+ test batches annually.
Five-Stage Quality Control System
From raw material receipt to batch traceability, every hemostatic dressing undergoes five rigorous inspections.
Incoming Inspection
Each raw material batch completes 12 physicochemical tests before warehouse entry: particle size distribution, purity, heavy metal content, and more. Non-conforming materials are rejected outright.
In-Process Control
Critical parameters monitored online every 15 minutes during production: coating thickness, moisture content, weight deviation.
Finished Product Testing
Random sampling per batch completes 18 release test items: hemostasis time, water absorption rate, tensile strength, EO residue, and more.
Sterilization Validation
Validated ethylene oxide (EO) sterilization cycles with dual biological and chemical indicator monitoring in every chamber.
Batch Traceability
Full-process scan-based records from raw material batch to finished product release, supporting reverse traceability to material suppliers with mandatory 10-year data retention.
4,000 sqm ISO Class 7 Aseptic Cleanroom
Manufacturing facility equipped with Class 10,000 (ISO 7) standard sterilization workshops, implementing 100% scan-based traceability from raw material batches to clinical release.
Batch Consistency Control
Mandatory particle size distribution and water absorption testing on every production batch ensures absolutely consistent hemostatic performance in the field.
Sterility Assurance Level
Rigorously validated ethylene oxide (EO) sterilization cycles with dual biological/chemical indicator real-time monitoring.
Data Integrity
All critical production parameters are digitally archived with mandatory 10+ year retention for audit and full-chain traceability.
4,000 sqm Aseptic Sterilization Cleanroom
Production Status: Ready for large-scale global shipment
Quality & Compliance FAQ
What quality certifications does Ruten hold?+
ISO 13485:2016 (TUV SUD certified), FDA facility registration, CE certification (EU MDR 2017/745), GMP production standards. Product performance meets CoTCCC tactical medical committee recommended standards. Also passed ISO 10993 full biocompatibility testing.
How does the batch traceability system work?+
Full-process scan-based records from raw material batch to finished product release, supporting reverse traceability to raw material suppliers. 100% batch traceability with all critical production parameters digitally archived and mandatory 10+ year retention for audit and full-chain traceability.
What sterilization validation methods are used?+
Rigorously validated ethylene oxide (EO) sterilization cycles with dual biological and chemical indicator monitoring in every chamber. Sterility Assurance Level (SAL) reaches 10^-6, ensuring product sterility.
Can you provide original compliance documents?+
Yes. We provide complete original ISO/FDA certificate scans, product test reports, DMR technical files, validation reports, and bilingual clinical white papers. Full support for institutional procurement due diligence and supplier onboarding audits.
Get the Complete Quality Compliance Dossier
Can your supplier provide complete original ISO/FDA certificates and 10-year batch traceability data? Conducting institutional procurement due diligence or supplier onboarding? Contact our compliance team for detailed original ISO/FDA certificate scans and product test reports. 100% batch traceability, 5,000+ annual test batches.