Design Controls for Medical Devices and IVDS
NSF International’s web-based virtual training course provides a basic understanding of Design Controls for medical devices and IVDs. Providing knowledge to comply with US FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016, and the European Union Medical Device Regulation (EU MDR). Learn from global Quality Systems expert, Kim Trautman, a former U.S. FDA official. Kim also authored the current U.S. FDA Quality System regulation and is a recognized leader of continued global regulatory harmonization efforts.
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.
For more information Visit University Website.
About NSF International
NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...
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