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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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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05/20/2019
Category: pharmaceutical consulting firms
The ability to bring some drugs to market faster can mean life or death for some patients. The U.S. Food and Drug...
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