Villarraga has conducted failure analyses, root cause analyses, and compliance evaluations related to medical device recalls. Villarraga has experience in 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, and finished device evaluations. FDA regulations to develop regulatory strategies for novel products, contribute or prepare regulatory submissions, and to support identifying and justifying technical evaluations for pre-market assessments and postmarket compliance matters.ĭr. Villarraga uses her knowledge of the U.S. As a Regulatory Affairs Certified (RAC-US) professional, Dr. Villarraga has provided technical support for due diligence, regulatory submissions, regulatory compliance, risk management, postmarketing surveillance, product development, product liability, and intellectual property matters. She has experience with orthopedic, spinal, plastic and reconstructive surgery, urology, urogynecology, general surgery, women's health, and diagnostic medical devices, with particular emphasis on biomechanics and biomaterial-tissue interactions with medical devices.ĭr. Villarraga has expertise in evaluation of medical device performance during the premarketing and postmarketing stages.
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