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Design Controls for Medical Devices and IVDs

About This eLearning

Duration: 4 hours

In addition to providing an in-depth discussion of contemporary design and development principles and practices (and corresponding EU and FDA regulatory requirements), this approximately four-hour, self-paced course explores the essential relationships between risk management and design and development throughout the lifecycle of a medical device.

This course is designed for risk management professionals, engineers, quality and regulatory professionals, and others engaged in design and development throughout the lifecycle of a medical device, as well as those managing risk management and design and development of medical devices.

Key Learning Objectives

By the end of this course, you will be able to:

  • Identify key risk management regulatory requirements
    • European Union
    • FDA’s Quality System Regulation
    • ISO 13485:2016
  • Identify key risk management principles of ISO 14971:2019
  • Identify key design control regulatory requirements:
    • European Union
    • FDA’s Quality System Regulation
    • ISO 13485:2016
  • Recognize potential exemptions from design control requirements
  • Identify when, during a design and development project, design control requirements apply
  • Conceptualize graphically a design control process

Who Should Attend

This course is important for medical device professionals, especially those who conduct or participate in design phases of any project and/or quality systems activities specific to design control.

Certificate

By completing/passing this course, you will attain the Medical Device Certificate.

Cost: $599 (per completion)

  • Very insightful!
  • Excellent introduction and overview.