Crisis Prevention and Recovery LLD (dba SoftwareCPR)

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We provide full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software, 62304, Human Factors and usability engineering, as well as hands-on validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.

Company Details

Address
10791 Sable Breeze Way
Boynton Beach, FL 33473

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