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FDA Blog

FDA CDRH, EU-MDR, Global Data Standards

FDA CDRH, EU-MDR, Global Data Standards

By William E. Spanogle, Ph.D.

  01/06/2022

  Category: pharmaceutical consulting firms

Start Up, Substantial Equivalence (SE), De Novo, and EU-MDR/IVDR Devices have high quality, affordable products that improve the quality of life for...

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FDA Redefines Term “Device”

FDA Redefines Term “Device”

By William E. Spanogle, Ph.D.

  01/02/2022

  Category: pharmaceutical consulting firms

In December 2021, the FDA Redefined their use of the term “Device”. Comprehensive compliant implementation of the FDA’s Medical Device Requirements hinges...

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