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How to Validate Cervical Plates Without Relying on Cadaver Tests: The IBV Experience
The biomechanical validation of a cervical plate poses a significant challenge for manufacturers of medical devices intended for spinal surgery.
What requirements does the MDR impose on a manufacturer outside the European Union?
The European market remains one of the main destinations for manufacturers of medical devices from countries such as India, China,
What is critical load in dental implants?
In dental implantology, one of the most relevant concepts from the biomechanical point of view is the critical load. This
Differences between MDR and MDD for manufacturers
The move from Directive 93/42/EEC (MDD) to Regulation (EU) 2017/745 (MDR) has brought about one of the biggest regulatory changes
What tests must a dental implant pass before it reaches the market?
The development of a implantable dental medical device does not end when the design is finalized. Before reaching the market,
Why should osteosynthesis plates be validated according to ASTM F382?
The osteosynthesis plates are implantable medical devices designed to stabilize bone fractures and allow for proper bone healing. During the
