Daniel E. McLain, PhD is President of Walker Downey & Associates, Inc., a medical product safety and development consulting firm and certified Veteran-Owned Small Business (cVOSB) located in the heart of the Third Coast Scientific/Biotechnology Community (Madison, WI). He received his MS/PhD in nutritional toxicology and preventive medicine from Cornell University and has more than 40 years of broad-based experience in toxicology, drug and device development, vaccine development, statistics, and risk assessment. He has specific expertise in medical device material biocompatibility, immunotoxicology, and was the recent AAMI US Chair for TC194/WG7 and convener of ISO 10993 – Biological Evaluation of Medical Devices – Part 11: Systemic Toxicity Evaluation (standard revised 2006; reaffirmed 2010; retired from position in 2023). He has contributed to and has meaningful personal experience with IND, BLA, 510(k), GTAC, CTD and MEDDEV 2.7.1 CER preparation. He is fully experienced with the design, conduct, analysis, and reporting of preclinical safety and pharmacokinetic studies for drugs, devices, biologics, and combination products, and with the international regulatory submissions associated with them.Specialties: Develop evidence-based solutions for medical device biocompatibility testing and conformance strategies for rapid product development. Prepare biocompatibility risk assessments for medical devices, toxicology risk assessments, preclinical study design and analysis, quality and regulatory consulting, MEDDEV 2.7.1 reports, and traditional and contemporary statistics.