CE marking technical file

Consists of:
Product description

  • Requirement specification
  • Usability specification
  • Applied standards

Risk management

  • Risk analysis
  • Risk mitigations

Design

  • Design rules
  • Configuration management
  • Traceability management
  • Release management

 

 

 

Manuals

  • User manual
  • Service manual

Verification

  • Verification management
  • Modules verification
  • System verification

Structured development process

Life cycle of development

  • Requirement specification and management
  • Configuration management
  • Project management
  • UML, agile methods