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Design Controls for Medical Devices and IVDS

NSF International
Training overview
2.5 hours
199 USD
English
Next start date: Inquire for more information - Online

Course description

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.

Training Content

Objectives

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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About supplier

NSF International

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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Reviews

Scott
(5)
Content was perfect, instructors very knowledgeable and gave great examples.
Scott Gisler
(5)
Content was perfect, instructors very knowledgeable and gave great examples.
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Training reviews
Design Controls for Medical Devices and IVDS
Course rating
(5.0)
Based on 2 reviews

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