QLeaR Advisors (QLeaR) specializes in providing compliance leadership, coaching, strategic and tactical quality system and regulatory compliance consulting to small and mid-sized med tech, biotech, and adjacent space companies. Services include quality management system assessment (audit) and due diligence, QMS design and improvement, change management, compliance remediation, QMS/compliance training and education, electronic solution selection and implementation, and interactions with notified bodies or regulators. Regulation expertise includes ISO 9001, 13485, 14000, 15189, 17025, 21 CFR 11, 58, 210/211, 312, 600, 812, 820, 1271, associated EU, and other OUS regulations.