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NMSDC Certified 2019 SBA Certified 2019

Category: Medical device consulting

FDA De Novo & Medical Devices

FDA De Novo & Medical Devices

By William E. Spanogle, Ph.D.

  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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Design Control Process for Medical Devices

By Christina Sanchez Miller

  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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Medical device consulting

Reporting Medical Device Adverse Events

By Christina Sanchez Miller, MPH

  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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