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PROGRESSIVE EXPERIENCE AND STRENGTHS:

●Medical Device ISO 13485, FDA CFR Title 21 Part 820, Tissue Regulations, Part 1270/1271, AATB Accreditations

●5 + Years risk assessment under ISO 14971:2019, ISO9001/AS9100, EU MDR 2017/745 and IVDR 2017/746 and 4+ years v ISO 10993-2018/2020 for...