US Regulations

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21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

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21 CFR PART 803-MEDICAL DEVICE REPORTING

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21 CFR PART 806-MEDICAL DEVICES_ REPORTS OF CORRECTIONS AND REMOVALS

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21 CFR PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

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21 CFR PART 820-QUALITY SYSTEM REGULATION

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21 CFR PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS

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US Guidance Documents

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Design Control Guidance for Medical Device Manufacturers

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Do It By Design

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General Principles of Software Validation

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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

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Medical Device Use-Safety Incorporating Human Factors Engineering into Risk Management

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Off-The-Shelf Software Use in Medical Devices

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Quality Systems Inspection Technique (QSIT)

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European Regulations

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Consolidated version of the Active Implantable Medical Devices Directive 90 385 EEC as amended)

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Consolidated version of the In Vitro Diagnostic Medical Devices Directive 98 79 EC as amended

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Consolidated version of the Medical Devices Directive 93 42 EEC as amended

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Medical Device Regulation 2017745

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Invitro Medical Device Regulation 2017746

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