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  • Home
  • Consulting
    Technical Documentation
    • Software (IEC 62304, FDA)
    • Risk Management (ISO 14971)
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    Regulatory Affairs
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    • Medical Device Directive
    • Classification
    • CE Marking
    • Conformity Assessment
    • Harmonized Standards
    • MEDDEV 2.7/1
    • And more ...
    QM System & ISO 13485
    • ISO 13485:2016
    • Quality Policy & Objectives
    • Process Validation
    • Audits
    • Unannounced Audit
    • MDSAP
    • CSV
    Software & IEC 62304
    • Software Lifecycle
    • Safety Classes & Level of Concern
    • SOUP and OTS
    • Medical Apps
    • IT-Security
    Risk Management & ISO 14971
    • Life Cycle Risk Management
    • Update 14971:2012
    • Harm and Severity
    • Hazard and Hazardous Situation
    • Risk Acceptance
    • Risk Mitigation
    • Risk Analysis
    • Software Specifics
    Usability & IEC 62366
    • Main Operating Functions
    • ISO 9241
    • User stories
    • Usability Validation
    Product Development
    • Intended Use Description
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    • Verification versus Validation
    • Clinical Evaluation
  • Regulatory Affairs
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    • IVD Regulation (IVDR)
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    • And more ...
      • Accessories
      • Essential Requirements
      • EUDAMED
      • MDR Rule 11 (Software)
      • MEDDEV Documents
      • Post-Market Surveillance
      • Notified Bodies
      • Premarket Approval (510k)
      • Technical File versus DHF
      • Unique Device Identification
      • Harmonized Standards
      • EU General Data Protection Regulation GDPR
      • 21 CFR Part 11: Requirements You Should Know
      • Design input: What you shouldn’t forget
      • Declaration of Conformity
  • QM System & ISO 13485
    • ISO 13485:2016
    • Quality Policy & Objectives
    • Process Validation
    • Audits
    • Unannounced Audit
    • MDSAP
    • CSV
  • Software & IEC 62304
    • Software Lifecycle
    • Safety Classes & Level of Concern
    • SOUP and OTS
    • Medical Apps
    • IT-Security
  • Risk Management & ISO 14971
    • Life Cycle Risk Management
    • Update 14971:2012
    • Harm and Severity
    • Hazard and Hazardous Situation
    • Risk Acceptance
    • Risk Mitigation
    • Risk Analysis
    • Software Specifics
  • Usability & IEC 62366
    • Main Operating Functions
    • ISO 9241
    • User stories
    • Usability Validation
  • Product Development
    • Intended Use Description
    • System Architecture
    • Verification versus Validation
    • Clinical Evaluation

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