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UL University Releases New Workshops for Medical Device Manufacturers

UL University is pleased to announce the release of our medical device compliance workshops for 2011. Upcoming topics include: Designing for Compliance to IEC 60601-1, 3rd Edition, Risk Management for Medical Devices: Compliance with ISO 14971 and more!

Register for any UL University public workshop or online training between now and February 20th and receive 10% off when you use discount code MED0111*.


Designing for Compliance to IEC 60601-1, 3rd Edition

Presented by experienced UL engineers and knowledgeable in evaluating products for certification to U.S. and international standards for medical equipment, this three-day workshop will help you gain an understanding of how to use IEC 60601-1 and UL 60601-ES-60601-1:2005 effectively.

Workshop objectives:

  • Recognize the full scope of IEC 60601-1, including the current US deviations in ANSI/AAMI ES 60601-1
  • Determine the applicable medical equipment requirements to design products for compliance
  • Identify with Risk Management concepts from ISO 14971 and practice their application according to 60601-1
  • Define insulation parameters and requirements
  • Click here for more

Dates and locations:

  • March 8-10 - Northbrook, IL
  • June 28-30 - San Jose, CA
  • August 16-18 - Research Triangle Park, NC

For more information and to register online, please click here.

Do you still want to learn about IEC 60601-1, 2nd Edition or the changes brought about with the issuance of IEC 60601-1, 3rd Edition? Attend our Designing for Compliance to IEC 60601-1, 2nd Edition and Transition to the 3rd Edition workshop.


Risk Management for Medical Devices: Compliance with ISO 14971

This one-day 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.

Workshop 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
  • Click here for more

Dates and locations:

  • January 25 - Brea, CA
  • August 3 - Northbrook, IL
  • December 15 - Research Triangle Park, NC

For more information and to register online, please click here.

Register for this workshop and Documenting Required ISO 14971 Risk Management File Elements in the IEC 60601-1 TRF and receive $125 off the registration fee. Click here for more information on the bundled workshop package.


Documenting Required ISO 14971 Risk Management File Elements in the IEC 60601-1 TRF

This one-day workshop gives medical device manufacturers a practical view of the process for documenting required ISO 14971 Risk Management file elements and clarifies information needed to support 3rd Edition Certifications. Participants will evaluate a fictional manufacturer’s Risk Management file for compliance with IEC 60601-1 by verifying the required documentation, completing applicable sections of the test report form (TRF) and finding the best way to document information through lessons learned.

Workshop objectives:

  • Determine the applicable medical equipment requirements to design products for compliance
  • Identify expectations and objective evidence needed to support certification
  • Recognize and apply new concepts from ISO 14971
  • Recognize and apply new concepts from IEC 60601-1
  • Click here for more

Dates and locations:

  • January 26 - Brea, CA
  • May 19 - San Jose, CA
  • August 4 - Northbrook, IL
  • December 16 - Research Triangle Park, NC

For more information and to register online, please click here.

Register for this workshop and Risk Management for Medical Devices: Compliance with ISO 14971 and receive $125 off the registration fee. Click here for more information on the bundled workshop package.


Additional UL University Workshops and Online Training

Contact UL University

For more information on UL University's offerings or to request a private and/or custom workshop, please call UL University at 1.888.503.5536, email ULUniversity@us.ul.com or visit www.uluniversity.com.

*Discount codes may not be combined with any other offer from UL University.

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