This video-based training course provides a basic understanding of design controls for medical devices and IVDs. It covers how to comply with the U.S. FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016 and EU MDR. Learn from global quality systems expert Kim Trautman, a former U.S. FDA official.
By the end of this course, you should be able to:
- Identify design control requirements based on US FDA quality system regulation, ISO 13485:2016, and EU MDR.
- Recognize how risk management ties in to the design control process.
- Recognize FDA’s auditing process and expectations of design controls.
- Identify appropriate application of design control requirements.
By completing/passing this course, you will attain the certificate Medical Device Certificate
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