Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management

Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management is a course that covers topics such as:

  • The requirements of ISO 14971
  • The risk management process, the activities, and deliverables as well as the organization framework necessary
  • Be able to conduct risk analysis team meetings
  • Developing a risk analysis framework document
  • How to apply ISO 14971 into development process
  • How and where to use the various techniques during the design life cycle
  • How your Risk Management system fits into quality system and business practices
  • How to document your Risk Management
  • Performing risk assessments effectively

Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management brings together:

  • Quality Professionals
  • Senior Quality Managers
  • Compliance Professionals
  • Regulatory Professionals
  • Risk managers
  • Project managers
  • Quality Assurance personnel
  • Engineering management
  • Software Engineers
  • System and design engineers
  • Verification / validation personnel
  • Usability Engineers
  • Quality Engineers
  • Production Managers
  • Medical Affairs Professionals
  • Quality Auditors

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