Medical Device Risk Management Using ISO 14971

Why Should You Attend:

ISO 14971:2007 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA. ISO 14971:2007 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA. Your Risk Management program should be able to answer these questions easily. If not, then your team needs to attend.

• Do you have a documented method to combine frequency and severity to calculate risk?
• Do have a formally approved Risk Management Plan that applies to your medical device?
• Do you apply risk reduction methods in the correct order?
• Have you documented the risk verification in the Risk Management Report?
• Does your manufacturing process control, especially validated processes, regularly update you Risk Management File?
• Have you integrated you complaint system with the Risk Management File to evaluate your frequency and severity estimates?

This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk. We provide an overview using flow charts that shows each of the elements of a Risk Management system and how they fit together. This approach helps the participant understand the essential structure and the required elements.

We will look at the elements of Risk Management, including the required documents. This includes: A risk management plan, risk evaluation documentation, risk verification activities, risk management report, risk management file, obtaining production information and linking complaints to provide post-production information.

You will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, and the records you must keep.

Areas Covered in the Seminar:

• An overview of ISO 14971 to place the presentation in context.
• FDA requirements for risk analysis as part of design validation.
• Recognition status of ISO 14971 by the FDA and for the EU MDD and IVDD.
• The GHTF guidance document on risk management principles.
• Developing a Risk Evaluation Matrix for your product.
• Failure Modes and Effects Analysis (FMEA).
• Fault Tree Analysis (FTA).
• Hazard Analysis and Critical Control Point (HACCP).

Who will Benefit:

This seminar is for quality, regulatory, production, and design people who may become involved in risk analysis or Risk Management. Because risk management is a life cycle approach, sales and service people may also become involved.

Attendees should understand design and manufacturing processes. Knowledge of complaint handling procedures and corrective action procedures is useful.

Because of the cross functional and cross discipline aspects, this is an ideal opportunity for team attendance. You need to ensure that all parties get the same message. People in the following roles can especially benefit from the knowledge in this webinar:

• Validation professionals
• Design Engineers
• Project Managers involved in Design and Development
• Quality Engineers assigned to validation activities
• Quality Auditors
• Managers
• Quality staff assigned to Customer Complaints or CAPA management

Instructor Profile:

Daniel 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 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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