Alan Marcovecchio
Co-founder & VP Clinical, Regulatory & Quality @Atacor Medical, Inc
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WORK HISTORY
Co-founder & VP Clinical, Regulatory & Quality @Atacor Medical, Inc
EDUCATION
University of Minnesota
MS, Electrical Engineering
Case Western Reserve University
BS, Electrical Engineering
SKILLS
ABOUT ALAN MARCOVECCHIO
25+ years of experience in the medical device industry, with core competencies in Clinical Studies, Quality Management Systems and Regulatory Affairs.Clinical Studies experience includes design, approval and execution of human clinical trials, ranging from early feasibility to pivotal trials for regulatory approvals and post-approval studies. Regulatory Affairs experience includes 510(k) submissions, original PMA submissions, FDA Advisory Panel Meetings and CE Marking for Medical Devices.Additional experience includes ISO 13485 & 21 CFR 820 Quality Systems, technical support of implanted devices in a hospital/clinic setting, animal studies, cadaver studies and algorithm design for implantable pacemakers/defibrillators.
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