Risk Management for Medical Devices: Compliance with ISO 14971 (On-Demand Webinar)

Description

The one and a half-hour on-demand webinar will teach the purpose of risk management as required by the regulatory authorities around the world at a high level. It provides a practical application that attendees will use as a model for applying risk management to their own situation. This webinar is a prelude to IEC 60601-1, 3rd Edition that requires the application of ISO 14971 to the design and manufacture of a medical device.

Workshop topics

• Risk management as used in IEC 60601-1  
• Risk management process
  
• Intent of risk management
  
• Applicability of specific requirements
  
• Essential performance 
• Programmable electrical medical systems 
• Risk management and the quality management system
  

Objectives

• Identify the major changes in IEC 60601:2005 (3rd Edition)
• Apply risk management requirements to the electromedical safety requirements
• Identify what specific risks you should consider
• Explore the options you have in applying risk controls
• Begin to apply risk management concepts to your QMS ISO 13485 compliant system

Target Audience

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

Click here for the minimum system requirements to access this course.

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.