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Understanding Heat Treat Assessments (CQI-9)

Training overview
Professional Course
Virtual Classroom
1 day(s)
From 375 USD

Start dates
375 USD
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Course description

Understanding ISO 14971:2019 Application of Risk Management to Medical Devices

This two-day seminar addresses all of the elements of the ISO 14971:2019 Application of Risk Management to Medical Devices, and defines it as a process within your organization. It provides an overview of the six steps of the Risk Management process and how it is managed as a process. An overview and examples of the Risk Analysis Tools listed in ISO/TR 24971:2019 is also included.

Who should attend?


No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.

Who Should Attend

Those who have direct responsibility for introducing new medical devices and/or a new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical devices development and improvement.

Training content

  • Chapter 1: What is Risk?
  • Breakout Exercise 1: Defining Risk for Medical Devices
  • Chapter 2: Managing Risk
  • Fundamental Risk Concepts
  • Risk Management Process
  • Management Responsibilities
  • Competence of Personnel
  • Breakout Exercise 2: Identifying Management Responsibility and Competency of Personnel
  • Risk Management Plan
  • Risk Management File
  • Breakout Exercise 3: Composing a Risk Management Plan
  • Chapter 3: Risk Assessment and Analysis
  • Risk Assessment
  • Risk Analysis Process
  • Intended Use and Reasonably Foreseeable Misuse
  • Identification of Characteristics Related to Safety
  • Identification of Hazards and Hazardous Situations
  • Risk Identification Methods
  • Risk Estimation
  • Breakout Exercise 4: Identifying Risk Elements
  • Chapter 4: Risk Analysis Tools
  • Preliminary Hazard Analysis
  • Fault Tree Analysis
  • Event Tree Analysis
  • Failure Mode and Effects Analysis (FMEA)
  • Hazard and Operability Study (HAZOP)
  • Hazard Analysis and Critical Control Point (HACCP)
  • Breakout Exercise 5: Using Risk Estimation Techniques
  • Chapter 5: Risk Evaluation
  • Risk Evaluation
  • Risk Acceptability
  • Breakout Exercise 6: Identifying Higher Level Risk Elements
  • Chapter 6: Risk Treatment and Control
  • Risk Control Option Analysis
  • Implementation of Risk Control Measures
  • Residual Risk Evaluation
  • Benefit-Risk Analysis
  • Risks Arising from Risk Control Measures
  • Completeness of Risk Control
  • Breakout Exercise 7: Conducting Risk Control Review
  • Chapter 7: Risk Management Monitoring and Reviewing
  • Evaluation of Overall Residual Risk
  • Risk Management Review
  • Production and Post-Production Activities
  • Breakout Exercise 8: Conducting Risk Management Review and Overall Residual Risk

Course delivery details

Course Duration: 2 Days - 8 Hours/day

About Omnex

Omnex, International Consulting, Training and Software Development Organization

Omnex is an international consulting, training and software development organization specializing in management system solutions that elevate the performance of client organizations. Omnex provides consulting and training services in Quality, Environmental, and Health and Safety standards-based management systems. Omnex also...

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