技术文档

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  D-723-14 Complying A Multi-Country Compatible Technical File

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  D-723-16 Clinical Evaluation

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  D-723-24 Sterilization
  Part 1: Basis And Terms

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  D-723-25 Sterilization
  Part II: Gamma Sterilization

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  D-723-26 SterilizationPart III: Ethylene Oxide

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  D-723-27 Sterilization
  Part IV: Determination Of A Population Of Microorganisms On Products (ISO 11737-1: 2018)

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  D-723-33 ISO 11607 Medical Device Packaging Validation

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  D-723-36 UDI Basics For FDA And EU: Unique Device Identifier (Based on GS1 Format)

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  D-723-41 EU MDR Technical File Structure

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  D-723-46 Application Of Risk Management To Medical Device Part 1:Concepts & Principles

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  D-723-48 IEC 60601 Safety And Essential Performance Of Medical Electrical Equipment

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  D-723-54 Creating CER Plan And Report – Practical Tips

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  D-723-60 Application Of Usability Engineering To Medical Device

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  D-723-68 IEC 62304 Software Validation

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  D-723-69 Cybersecurity

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