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.
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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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