Risk Assessment in Medical Device Development

Instructor: Charles H Paul
Product ID: 704803
  • Duration: 90 Min
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This medical device risk assessment webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective device Risk or Hazard Analysis.

Why Should You Attend:

The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.

The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.

The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.

Learning Objectives:

  • Define Risk Assessment
  • Define the regulatory requirements that focus on medical device risk analysis
  • Define the Risk Management Process and the Risk Management Plan
  • List and describe the risk assessment documentation that must be developed and maintained
  • List and describe the techniques to be applied when conducting a risk analysis
  • List and explain the questions that must be asked when conducting a risk analysis
  • Identify and discuss the key evaluation/analysis tools – FTA, FMEA, and FMECA
  • Explain how risk is mitigated and controlled

Areas Covered in the Webinar:

  • Definition of risk analysis
  • Importance of risk analysis
  • Regulatory requirements
  • Management responsibilities
  • Risk management process
  • Risk management plan
  • Risk management documentation
  • Risk analysis processes and techniques
  • Risk evaluation tools
  • Risk control and mitigation

Who Will Benefit:

The following professionals from medical device companies will benefit from this training:

  • Design Engineers
  • Process Engineers
  • R & D Engineers
  • Project Owners and Managers
  • Scientists
  • Technicians
  • Compliance personnel
Instructor Profile:
Charles H Paul

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.

The firm works globally completing projects throughout the EU, UK, South America, and Asia.

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