Design Controls for Medical Devices and IVDs (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

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.