ComplianceOnline

Device Design and Risk Management

Instructor: Daniel O Leary
Product ID: 704561
  • Duration: 90 Min
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Read Frequently Asked Questions

As medical device requirements and expectations increase, coupled with strengthened standards, the design project must seek every opportunity to leverage activities in the area to satisfy requirements in other areas. This reduces the total work and helps make these processes more efficient. By attending this presentation, you will learn techniques to improve your device design project.

Bonus Material:

A chart showing the relationships between the clauses of EN ISO 13485:2012 and EN ISO 14971:2012.

Why Should You Attend:

Risk management and device design run in parallel tracks as elements of the same project. The two processes communicate and influence each other. For example, risk reduction measures become design inputs. Implementation verification required by risk management could also be design verification.

The device manufacturer must incorporate both aspects into any design project to ensure the device is safe and well designed. This presentation identifies design requirements in the current Quality Management Systems, QMS, (QSR, ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, and EN ISO 13485:2016) that relate to risk management. It also identifies the risk management requirements in the common Risk Management Systems, RMS, (ISO 14971:2007 and EN ISO 14971:2012) that relate to design control.

The presentation examines the linkages and interactions between the QMS and the RMS, including how specific area requirements in one system could meet the requirements in the other system. Planning these activities can reduce the total workload helping to make a safe device in a more efficient project.

In addition, product safety standards, meeting certain criteria, can “automatically” satisfy some design control and risk management activities. Application of these standards can further improve project efficiency.

Areas Covered in the Webinar:

  • Provide an overview of design control from the risk management perspective
  • Provide an overview of risk management from the design control perspective
  • Illustrate where the two system interact
  • Identify areas where the activities in system support, or even complete, the requirements in the other system
  • Learn how to use product safety standards to improve design control and risk management efficiency

Who Will Benefit:

  • Quality Managers
  • Design Engineering Managers
  • Production Managers involved in production and process changes
  • Quality Engineers
  • Design Engineers
  • Manufacturing Engineers
  • Regulatory Affairs Managers
  • Risk Management Professionals
Instructor Profile:
Daniel O Leary

Daniel O Leary
President, Ombu Enterprises, LLC

Dan O’Leary 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 of 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 holds an APICS certification in Resource Management.

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