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Risk Management for Medical Devices: Compliance with ISO 14971 and Meeting Risk Management Compliance Expectations for the 3rd Edition of IEC 60601-1 (Bundled Workshop)


Description

This bundled two-day workshop combines UL Knowledge Services one-day Risk Management Compliance with ISO 14971 workshop with our one-day Meeting Risk Management Compliance Expectations for the 3rd Edition of IEC 60601-1 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. 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.

To view the complete course description, click here

Meeting Risk Management Compliance Expectations for the 3rd Edition of IEC 60601-1

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. All clause references will be to ISO 14971:2000 unless noted.

Each participant will receive a copy of the guideline document designed by the IEC Risk Management Task Force.

It is recommended that participants bring a copy of the IEC 60601-1, 3rd Edition and ISO 14971 Risk Management standards.

To view the complete course description, click here

Target Audience

  • Product and safety compliance engineers
  • Product designers
  • Engineering consultants
  • Regulatory affairs professionals
  • Product support engineers
  • Quality assurance staff
  • Technical marketing professionals

Recommended and Related Training

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Media

Time Requirement

Cost

Instructor-Led 2 days $1,125.00

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