Risk Management Using ISO 14971:2007 and EN ISO 14971:2012

Duration: 90 Minutes
Risk management is essential to device design and required by other standards, such as usability engineering, biocompatibility and electrical safety. The basis is ISO 14971:2007, but many companies don't understand the standard, don't follow the process flow, and consequently don't have an effective implementation. This presentation helps you avoid the common problems and create a compliant system.
ISO 14971:2007
Instructor: Daniel O'Leary
Product ID: 501829
Objectives of the Presentation
  • Learn the regulatory status of the versions of the standards
  • Understand the basic process flow and the EU variant
  • Learn the required elements in the Risk Management Plan
  • Evaluate estimated risk for acceptability
  • Learn the three stage hierarchy of risk reduction measures
  • Understand the requirements for verification and how to perform them
  • Learn the required elements of the Risk Management Report
Why Should you Attend
The international standard for medical device risk management is ISO 14971:2007. As a process standard, it describes a sequence of steps that starts with the possible harms to the patient or user, changes the device design to reduce the risk to an acceptable level, ensures implementation, and communicates information. EN ISO 14971:2012 uses the same model, but modifies some steps based on the EU directives.

This presentation explains the process flow and the EU variant based on the MDD. The first portion, running in parallel with the device design, starts with a Risk Management Plan and ends with a Risk Management Report based on a process review. The second portion uses information from production and device use to update risk information, analyze changes, and re-evaluate risk acceptability.

Who will Benefit
Because risk management is both cross functional and cross discipline, a team, linked with the design team, is important. People in the following roles can especially benefit from this presentation:
  • Risk Managers
  • Verification and Validation Professionals
  • Design Engineers
  • Project Managers involved in Design and Development
  • Quality Engineers assigned to verification and validation activities
  • Quality Auditors
  • Quality staff assigned to Customer Complaints or CA&PA management
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Instructor Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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