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Marta Villarraga

Ph.D., RAC-US ·

Philadelphia, Pennsylvania
evaluation of medical device performance
orthopedic, spinal, plastic and reconstructive surgery, urology, urogynecology, general surgery, women's health, and diagnostic medical devices
biomechanics and biomaterial-tissue interactions with medical devices
regulatory submissions
regulatory compliance
risk management
postmarketing surveillance
product development
product liability
intellectual property matters
identifying scientifically justifiable methodologies for assessment of medical device performance
evaluating quality control issues as applied to medical devices and pharmaceuticals
medical device quality systems compliance (gap analysis)
contamination
manufacturing compliance
finished device evaluations
failure analyses
root cause analyses
compliance evaluations related to medical device recalls
spine biomechanics
implant and tissue retrieval analysis
microscopic (SEM) and tissue analysis techniques (ICP, histology)
use of animal models for evaluating orthopedic/spinal device performance
experimental and finite element stress analysis techniques to characterize the mechanical behavior of bone, other biological structures, and orthopedic/spinal implant devices

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