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Introduction to ISO 14971: Risk Management

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: US$295.00
  • Refund Policy

Overview:

The term "Risk Based Processes" as become the latest trend in all aspects of medical device design, manufacture, test. distribution or service.

From the establishment of the Product Requirement Specification down to the service and maintenance processes, risk management is now the latest requirement in the medical device industry. Since its inception in 2000 and the amendments of 2003 the current version of ISO 14971 - Medical Devices - Application of risk management to medical devices, has been the industry standard for the establishment and implementation of a Risk management process. Whether your organization is making a simple Class I device or providing ground-breaking technology through the PMA process, the need for risk-based processes is required. This webinar will provide a basic overview of the ISO standard and provide the attendee with the basic knowledge of what is expected from an organization in regards to risk management.

Areas Covered in the Session:

  • A Basic overview of ISO 14971:2007 including
  • Management Responsibilities
  • Risk Analysis
  • Risk Evaluation
  • Risk Control and Risk Reduction
  • Risk Management Reports
  • Risk Management Files

Who Will Benefit:

  • Design Engineers
  • Software Engineers
  • Quality Assurance Personnel
  • Program Managers
  • Manufacturing Engineers
  • Regulatory Personnel
  • Engineering Managers
Speaker Profile
Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in all activities related to Quality Assurance and Regulatory Affairs such as Creation and maintenance of SOPs, FDA, Health Canada and CCC submissions as well as served as Director of quality for several of Analogic's Business Units. Chuck also conducts in-house training on a variety of subjects. Chuck is the Regulatory Affairs representative on all of the Analogic Project Teams and provides an oversight of the Risk Management process.


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