As an experienced entrepreneur, business angel, and medical device expert, I am engaged in advising medical device startups, providing leadership in the development of medical devices from concept to market release throughout all design phases to meet regulatory compliance and to shorten time of CE mark and FDA approval. As the co-founder of AiMorphous Health, I am currently fundraising our seed round.AiMorphous is an early-stage startup developing a groundbreaking blood diagnostic technology to detect the risk of thrombosis (blood clots) at an early stage. Our innovative approach has the potential to revolutionize the way we identify and manage thrombosis, a condition that can lead to life-threatening events such as heart attacks and strokes.My Regulatory Expertise • Medical Device Expert for MDR 2017/745 and IVDR 2017/746• FDA expert for 21 CFR 820 and 21 CFR 210/211 and 21 CFR 4• FDA expert for IDE, 510(k) and PMA • Auditor ISO 13485, ISO 9001, MDSAP and GMP• Material Science and Biocompatibility • Clinical Evaluation & Clinical Studies• Risk Management, Usability and Human Factor Engineering