Shuangyang Building, Yangshe Town, Zhangjiagang City, Jiangsu Province, China.
Shuangyang Building, Yangshe Town, Zhangjiagang City, Jiangsu Province, China.
Incorporating Surgeon Feedback in Early-Stage Proximal Humerus Plate DesignThe Importance of Clinician-Driven Design in Trauma Implant DevelopmentGetting input from surgeons while developing proximal humerus plates helps cut down on problems after su...
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Understanding Global Labeling Language Requirements for Sternum Titanium PlatesThe importance of multilingual labeling for implantable medical devicesHaving labels in multiple languages helps surgical teams understand important information about ster...
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Regulatory Expectations for CAPA in Fibula Plate Manufacturing The Role of CAPA in Ensuring Patient Safety and Device Quality Effective Corrective and Preventive Action (CAPA) systems reduce fibula plate failure risks by 58% in post-market surveill...
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Definition of substantial equivalence under FDA 510(k) regulationsSubstantial equivalence requires modified distal humerus plates to demonstrate comparable safety and effectiveness to legally marketed predicate devices through technical, biological, ...
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Understanding FDA Breakthrough Device Designation and Its Relevance to Minimally Invasive Spine Systems Breakthrough Device Designation (BDD) Criteria, With Emphasis on Criterion 1: More Effective Treatment for Irreversibly Debilitable Conditions T...
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Defining Clinical Evidence for Spinal Fusion: Regulatory and Payer Requirements Understanding Clinical Evidence in the Context of Spinal Fusion Claims To build strong clinical evidence supporting spinal fusion surgery, doctors need to combine severa...
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Understanding the Regulatory Framework for Lumbar Fusion CagesEffective marketing claims alignment for lumbar fusion cages requires navigating complex regulatory landscapes. Manufacturers must balance promotional messaging with strict submission requ...
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Understanding UDI and Its Importance for Locking Screw OrthopedicsWhat makes UDIs so important for orthopedic implants? Let's take locking screws as an example these are the ones that hold broken bones together during healing. According to recent FDA...
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Understanding Global Regulatory Requirements for Proximal Femoral Locking PlateCore Principles of Medical Device Regulation in Key MarketsThe FDA classifies proximal femoral locking plates as moderate risk devices (Class II) according to regulation 2...
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CE Marking as a Legal Gateway to the European Economic Area (EEA) Understanding CE marking requirements for medical devices in the EU Getting CE marking approval is essential when bringing titanium clavicle plates into Europe. The rules set out in M...
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FDA Class I–III vs. PMDA Class I–IV: Structural Differences in Risk CategorizationThe FDA classifies medical devices into three risk tiers (Class I–III), while Japan’s PMDA uses four categories (Class I–IV). This structu...
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Understanding EU MDR Requirements and Reclassification of Maxillofacial Trauma ImplantsKey Differences Between MDD and MDR Impacting Implant ClassificationMoving from the old Medical Devices Directive to the new EU Medical Device Regulation has reall...
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