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FDA Blog

medical device expert

Implementation of HFE Principles in Medical Device Design

By Christina Sanchez Miller, MPH

  05/20/2019

  Category: FDA 510k consultant

Healthcare facilities consist of complex, multi-faceted work systems. The introduction of new medical devices in these systems can result in undesirable events...

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FDA’s Expedited Pathways

By Christina Sanchez Miller, MPH

  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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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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Essure Expert Witness

Balancing FDA Compliance in a Pharmaceutical Environment

By Christina Sanchez Miller, MPH

  05/12/2019

  Category: Research

Regulatory compliance is a significant topic among quality management personnel. In a pharmaceutical environment, failure to comply with FDA regulations can have...

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