Shuangyang Building, Yangshe Town, Zhangjiagang City, Jiangsu Province, China.
Shuangyang Building, Yangshe Town, Zhangjiagang City, Jiangsu Province, China.
Why Packaging Integrity Validation Is Critical for Distal Radius Locking Plates The distal radius locking plates need to be completely sterile when they go into patients. If the packaging gets damaged somehow, these orthopedic implants become vulnera...
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Why Titanium Mesh Composite Demands Specialized Sterilization Methods Key material properties affecting sterilization compatibility The porous structure and mixed makeup of titanium mesh composites present some real problems when it comes to sterili...
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Regulatory Foundations: EU GMP Annex 1 and ISO 14644 AlignmentEU GMP Annex 1 requirements for aseptic processing of sterile orthopedic implantsThe EU GMP Annex 1 sets out pretty strict rules when it comes to keeping things sterile during the producti...
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Why Predictive Maintenance Is Critical for Rib Plate Surgical TraysHospitals are changing their game when it comes to managing those tricky surgical tray sets with specialized rib plates. Instead of waiting until something breaks or randomly replacin...
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How Supplier Audit Frequency Directly Affects Trauma Locking Plate Quality Material consistency, dimensional accuracy, and fatigue resistance under audit-deficient conditions When companies don't conduct enough supplier audits, three important quali...
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Understanding the Cost-Quality Imperative in Distal Humerus Plate ManufacturingFor patients recovering from orthopedic injuries, distal humerus plates need to be strong enough to support healing but not so expensive that hospitals struggle to afford ...
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The Importance of Cleaning Validation for Orthopedic ImplantsEnsuring patient safety through effective cleaning validation of trauma implantsCleaning validation simply cannot be ignored when it comes to trauma implants such as the Synthes calcaneal p...
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Regulatory Foundations: FDA, AAMI ST79, and ISO 17664 Requirements for Reprocessing Instructions Validation Validating reprocessing instructions for reusable orthopedic instruments is foundational to patient safety and regulatory compliance. Hospital...
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Material-Specific Laser Marking for Optimal Durability Laser Annealing vs. Etching on Titanium and Stainless Steel Laser annealing produces long lasting, high contrast markings on medical grade titanium and stainless steel by creating a permanent ox...
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Concentrated Global Production: The Core of Orthopedic Implant Supply Chain Risk Orthopedic implant makers face a serious problem because most of the world's ASTM F136 compliant titanium sponge comes from just a few places. This titanium sponge is b...
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Standardizing Core Manufacturing Processes for Multi-Site ProductionMaterial Specifications, Heat Treatment, and Surface Finish HarmonizationGetting consistent manufacturing results across different production sites starts with making sure all the ma...
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Ensuring Patient Safety and Material Biocompatibility Through ISO 13485 ISO 13485 certification for medical device material suppliers: A foundation for patient safety The ISO 13485 standard creates what many call a risk-focused quality system that's ...
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