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Regulatory Strategy, QMS, and 510(k) for Sleep Tracker Device
Develop a regulatory strategy and implement a quality management system, and submit a 510(k) for a AI sleep tracker device.
Bioprinter Go-to-Market Strategy
Developing a go-to-market strategy for a novel 3D bioprinting technology (featured on the cover of Science)
Atrial Fibrillation Competitive Landscaping
Investigating competitive pipeline for cardiovascular devices for atrial fibrillation (AF) procedures.
Gallbladder Therapy Competitive Analysis and Market Assessment
Understanding market need and competition for a gallbladder surgical technology company.
Surgical Adjuvant Company Due Diligence
Evaluating investability by performing comprehensive due diligence on a medical device startup.
Regulatory CRO Marketing Strategy
Developed initial marketing strategy for a clinical and regulatory contract research organization.