Risk Management for Medical Devices: Compliance with ISO 14971

Description

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This workshop teaches the purpose of risk management as required by the Regulatory Authorities around the world. It provides a practical application that attendees will use as a model for applying risk management to a given situation. Additional exercises include: developing a risk management policy and a risk management plan for a specific device, as well as, identifying hazards and risk control options. This seminar is a prelude to the third edition of IEC 60601-1 that requires the application of ISO 14971 to the design and manufacture of a medical device.

Workshop Topics

• Introduction to risk management
• Risk management policy and plan
• Intended use and hazard identification 
• Risk estimation and evaluation
• Option analysis and risk control
• Overall residual risk evaluation
• Risk management report and post production information

Objectives

• Identify the emerging global requirements for risk management
• Explain the scope and limitations of ISO 14971
• Determine how a risk management system fits into a quality management system
• Identify how and where to use the various tools for risk management
• Apply ISO 14971 to a class example in terms of risk analysis, risk evaluation and risk control

Target Audience

• Product safety and compliance engineers
• Product designers
• Engineering consultants
• Regulatory affairs professionals

Continuing Education Units (CEUs)

Contact your local jurisdiction for CEU recognition.

UL University's workshops are designed for and intended to serve individuals using and relying upon UL services. UL University reserves the right to limit workshop attendance strictly to the foregoing. In addition, UL University reserves the right to change, reschedule or cancel any workshop at any time. UL shall not be responsible for any consequential or other losses resulting from the cancellation or postponement of this workshop such as airline and other travel/personal expenses.

UL University accepts the following forms of payment for registration: Visa, MasterCard, American Express and Invoice/PO. Please note that Invoice/PO is not accepted for online courses.