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Who should attend Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management
Senior Quality Managers, Quality Professionals, Regulatory Professionals, Compliance Professionals, Project managers, Risk managers, Engineering management, Quality Assurance personnel, System and design engineers, Software Engineers, Usability Engineers, Verification / validation personnel, Production Managers, Quality Engineers, Quality Auditors, Medical Affairs Professionals
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Senior Quality Managers, Quality Professionals, Regulatory Professionals, Compliance Professionals, Project managers, Risk managers, Engineering management, Quality Assurance personnel, System and design engineers, Software Engineers, Usability Engineers, Verification / validation personnel, Production Managers, Quality Engineers, Quality Auditors, Medical Affairs Professionals

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Seminar Summary:

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. (see full course description)

 
 
 

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Training Course Syllabus:


Learning Objectives:


Upon completing this course participants should:



  • Understand the risk management process, the activities, and deliverables as well as the organization framework necessary
  • Be able to Interpret and discuss the requirements of ISO 14971

  • Develop a risk analysis framework document

  • Be able to conduct risk analysis team meetings

  • Recognize how and where to use the various techniques during the design life cycle.

  • Understand how to apply ISO 14971 into development process

  • Know how to document your Risk Management

  • Explain how your Risk Management system fits into quality system and business practices.

  • Perform risk assessments effectively


Seminar Summary:

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. (see full course description)

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