10
Oct
Mastering EU MDR Technical Documentation
The European Union’s EU MDR (Medical Device Regulation 2017/745) sets strict rules for technical documentation. Knowing these
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Biological Evaluation
Biological indicator testing
CDSCO Licensing
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Chemical Characterization
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Cytotoxicity
Device Master File
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Genotoxicity
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ISO 10993
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ISO 11137 radiation sterilization
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ISO 17665 moist heat sterilization
ISO 22441 hydrogen peroxide sterilization
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Medical Device Approval
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Regulatory compliance CDSCO USFDA EU MDR
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