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Certifications & Quality Assurance

Building Trust Through Certified Orthopedic Implant Manufacturing


At Geasure Medical, quality and safety are at the core of everything we manufacture. With internationally recognized certifications, advanced manufacturing capabilities, and strict quality control systems, we provide reliable orthopedic implants and surgical instruments for global healthcare partners.

QUALITY & COMPLIANCE

International Medical Device Certifications

Globally recognized standards that ensure safety, performance, and regulatory compliance.

13485

ISO 13485

CE MDR -Spine System

CE MDR -Spine System

CE Certificate2026

CE MDR -Intramedullary Nail System

CE MDR -Intramedullary Nail System

CE MDR -Locking Plate System

FDA1

FDA

dnv

MDSAP

9001

9001

MDSAP2023

MDMA(intramedullary Nail System)

Global Product Registrations

Supporting Healthcare Partners Across International Markets

Geasure Medical products are registered in multiple countries and regions, helping our partners efficiently enter local healthcare markets.


Our global registration experience enables us to provide professional regulatory support and customized solutions for international distributors.

Global Product Registrations

PRODUCT FAMILY

Our Quality Management System

Strict Quality Control from Raw Materials to Finished Products

Every orthopedic implant manufactured by Geasure Medical follows a comprehensive quality control process.


Our quality management system ensures product consistency, dimensional accuracy, safety, and reliable performance throughout every manufacturing stage.

01

Incoming Inspection

All raw materials undergo professional inspection before manufacturing.

02

Precision Machining

High-precision 5‑axis CNC machining with medical‑grade materials (Ti / PEEK).

03

Surface Treatment

Advanced coating & anodizing to improve biocompatibility and wear resistance.

04

Cleaning & Packaging

Professional cleaning and packaging procedures maintain product safety.

05

Quality Inspection

100% traceable quality control — every batch meets ASTM / ISO 13485 requirements.

06

Sterilization & Packaging

Gamma / ETO sterilization and sealed packaging ensuring sterile delivery to hospital.

07

Final Quality Inspection

Each product is inspected before shipment to ensure compliance with specifications.

08

Logistics & Support

Global logistics, technical training, and on‑site surgical support available.