Shuangyang Building, Yangshe Town, Zhangjiagang City, Jiangsu Province, China.
Shuangyang Building, Yangshe Town, Zhangjiagang City, Jiangsu Province, China.
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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Overview of FDA Classification and Regulatory Framework for Lumbar Artificial DiscsClassification of lumbar artificial discs as Class III medical devicesLumbar artificial discs fall under Class III medical device status according to the FDA, which is...
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Understanding the FDA 510(k) Process and Substantial Equivalence for Distal Tibia PlatesCore requirements of the FDA 510(k) clearance process for orthopedic implantsManufacturers wanting faster FDA 510(k) approval for distal tibia medial plates need ...
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Understanding Dimensional Accuracy in Patient-Matched Tibia PlatesDefining Dimensional Accuracy in Patient-Specific Osteosynthesis PlatesWhen we talk about dimensional accuracy for those custom made tibia plates, we're basically looking at how well t...
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Understanding the FDA 510(k) Process for Distal Radius Volar Locking Plates The Role of 510(k) Clearance in Orthopedic Device Market Entry Getting FDA 510(k) clearance marks a major step forward for companies wanting to sell volar locking plates in ...
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Understanding IP Protection in 3D-Printed Medical Implants The Role of Intellectual Property in Additive Manufacturing Medical Devices Protecting intellectual property really matters when it comes to pushing forward innovations in medical device ma...
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Understanding the Design Transfer Process for 3D-Printed Clavicle PlatesDefining Design Transfer in the Context of Additive Manufacturing for Orthopedic ImplantsThe process of design transfer in additive manufacturing involves moving those carefully ...
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Clinical Need Driving Surgeon Demand for Custom Rib Plating Understanding the limitations of off-the-shelf implants in complex rib trauma Conventional rib plates fail to accommodate anatomical variability in 95% of thoracic trauma cases requiring o...
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Unique Challenges in Sterilization Validation for Porous 3D-Printed Titanium Implants Sterilization Challenges Specific to Porous Structures in 3D-Printed Orthopedic Implants The complex web-like structures in 3D printed titanium implants present r...
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Understanding Cleanroom Classification in the Context of 3D-Printed Implant AssemblyISO 14644-1 Cleanroom Classification Based on Airborne Particle CountsCleanroom standards under ISO 14644-1 look at how many particles ≥0.5 microns there are in ea...
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Classification of 3D-printed titanium cranial implants: Class II medical devices and patient-specific considerationsAccording to the Food and Drug Administration, those 3D printed titanium mesh pieces used for skulls fall into the Class II category o...
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