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)