May 9 – 10, 2024
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:
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.
ISO 13485:2016 Overview and Country-Specific Medical Devices Regulations: Six-Course Bundle
Post-Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
Deviation Investigations and CAPA