Sol MedTech – Founder, Principal Consultant    https://sol-medtech.com/

indieMedTech – Co-Founder

Subject Matter Expert having 20+ years of medical device Quality, Regulatory and Clinical Affairs experience in developing global regulatory strategies; CE Mark MDD/MDR technical documentation, CEP/CER, PMCF Plans, Studies & Reports; FDA submission preparation and facilitation of clearance/approval, including Pre-sub, IDE, De Novo, 510(k), Emergency Use Authorization; new product design and development, human factors engineering, risk analysis (ISO 14971), biological risk assessment (ISO 109931), animal studies; clinical trial design, protocol, report, IRB coordination, clinical study management; remediation; internal audits, QMS Development (ISO 13485 Certification, 21CFR); acting Management Rep, supporting FDA inspections and NB audits. 14+ years of consulting experience with 80+ companies ranging from start-ups to large medical device and pharmaceutical companies. Served as sponsor correspondent for 20+ product (all classes) submissions for regulatory clearance/approval to market, including those with challenging regulatory pathways, including Rx to OTC, pediatric devices, NSE decisions, deficiencies, 483s, and products associated with consumer safety communications. Experience with people, project, client, and resource management.