Michael Wetherington is the founder of DocuRegs and the author of multiple publications focused on regulatory, quality, and system behavior in MedTech.
With more than 25+ years of experience spanning regulatory affairs, quality systems, product certification, and medical device engineering, Michael’s work centers on how compliance actually emerges or breaks down inside complex organizations. Rather than treating regulatory approval or quality outcomes as isolated goals, he focuses on designing systems that maintain control as complexity increases.
His career spans the full MedTech ecosystem, including accredited testing laboratories, notified bodies, and R&D-driven manufacturers. He has supported technologies ranging from non-active medical devices to complex systems such as rapid infusion pumps and emerging robotic platforms. This cross-functional exposure informs his perspective on why issues recur even in compliant environments, and how decision-making, handoffs, and feedback loops shape regulatory and quality outcomes over time.
Michael actively supports organizations operating within FDA, EU MDR, UKCA, and ASEAN frameworks, with a particular interest in preserving engineering intent while meeting evolving regulatory expectations.
At DocuRegs, his approach emphasizes alignment between regulatory intent, quality system behavior, and engineering execution. The objective is not faster documentation or isolated fixes, but integrated control that enables predictable outcomes, reduces late-stage surprises, and supports sustainable scale.
Beyond MedTech, Michael brings entrepreneurial experience across industries including hospitality, entertainment, product testing, and e-commerce. This broader business background reinforces his systems-level perspective on growth, risk, and organizational behavior.
Through DocuRegs, Michael provides structured thinking, practical frameworks, and leadership-level insight for teams seeking not just compliance or approval, but durable control embedded in how their systems operate.
