Design Controls for Medical Devices and IVDs

On-Demand4 hours

$599 (per completion)Register

Course Overview

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.

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Additional Recommended Courses

Design Controls for Medical Devices and IVDs

This virtual instructor-led two-day course covers design control principles and design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated.

This course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development principles, including the interrelationship of risk management and design and development throughout the lifecycle of a device.  This course includes interactive group activities relative to all phases of design and development.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify key regulatory requirements for risk management
    • European Union
    • Quality System Regulation
    • ISO 13485:2016
  • Identify key principles of ISO 14971:2019
  • Identify key regulatory requirements for design controls:
    • European Union
    • 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 class is vital for any medical device research and development professional, regulatory scientist, and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.

Price: $1200.00