inspection and warning letter response

Evergreen Strategic Consulting, LLC is the consulting practice of Dr. Carrie M. Huffman, MA, MPH, LPD, RAC, providing regulatory, clinical, and policy consulting for the medical device industry. With over 25 years of experience in epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy, she offers expertise in regulatory affairs, clinical evidence, patient preference and engagement, and advocacy for patient-centric healthcare policy.

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clinical affairs SOP developmentEU MDR strategy, readiness and submissionIDE study design and executionmedical device Early Feasibility Studies (EFS)observational and interventional study designpatient interviews and focus groupspatient preference studiesPMS, PMCF, CEP, CER, PSUR and SSCP developmentpolicy position development and writingpost-market data collection, analysis, and trendingquality system development, review, and compliancerecall review, documentation, and implementationregulatory authority engagementregulatory strategy developmentsurvey studies