Nov 2, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. Apart from other matters, the document addresses the ones related to the design history...
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Oct 28, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. The document is intended to provide additional clarifications regarding the applicable...
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Sep 22, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to design control. The document covers the regulatory matters related to design verification and...
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Sep 14, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document on design control for medical devices. The document provides additional clarifications and recommendations to be...
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Aug 30, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. The scope of the document covers such aspects as design input and design output. The...
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