Creating the ISO 14971:2007: Developing the Risk Management File

Why Should You Attend:

The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management’s risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of your risk management process will suffer. You won’t have the necessary information to make decisions or ensure qualified people are involved in the process. An ineffective process could result in an audit nonconformance from your Notified Body or even a Warning Letter from the FDA.

While there are only six mandatory areas for the RMP, they require a lot of information and involve some difficult decisions. While the mandatory areas don’t change between ISO 14971:2007 and EN ISO 14971:2012, the details can be significantly different.

To create an effective Risk Management Plan (RMP) you must understand the details behind the mandatory areas. For example, there are many issues in defining risk acceptability. Moreover, the application of risk evaluation and the need for risk control may change between the international version and the European version of the standard. This presentation provides the information you need to write a compliant and effective RMP. Your well-written and comprehensive plan offers significant contribution to the project’s success.

Areas Covered in the Webinar:

• The scope of the plan and its relationship to the device life-cycle
• Assignment of responsibilities and authorities and a valuable tool to help manage them
• Review of risk management activities
• Criteria for risk acceptability including distinctions between the international and EU versions
• Special cases of risk acceptability that can often reduce the risk management workload
• The necessary verification activities (implementation and effectiveness) and how they can link to the QMS
• Collection, review, evaluation, and action from production and post-production information collection

Who Will Benefit:

All medical device manufacturers must implement risk management

• Top Management
• R&D Managers
• Risk Managers
• Project Managers
• Risk Management Team Members
• Design Project Team Members
• Complaint Specialists
• MDR Specialists

Instructor Profile:

Dan O'Leary is 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 certified by APICS in Resource Management.

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