02/02/2022
Category: Medical device consulting
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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07/19/2019
Category: Medical device consulting
The FDA requires registered establishments to comply with Current Good Manufacturing Practices (CGMP), and there are specific regulations for each industry, such...
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05/15/2019
Category: Medical device consulting
Errors associated with medical devices can be costly to health institutions and manufacturers, with some patients paying the ultimate price with their...
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