Bridging Regulatory, Quality, and Engineering
Designing systems where compliance emerges from control.
Our Integrated Control Product Collection and Services
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𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 𝗥𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 Consulting
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This is a complimentary e-booklet.
ICDS Modules 0-2 System Foundations
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ICDS Modules 3-5 Governance and Oversight
Coming Soon !
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Our Founder and CEO
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.
About Us
DocuRegs focuses on how regulatory, quality, and engineering systems actually behave in practice, particularly as organizations scale, introduce change, and operate under increasing regulatory pressure.
Rather than treating compliance as a checklist or quality as a standalone function, DocuRegs examines how control is established, maintained, or lost across decisions, handoffs, and feedback loops. This system-level perspective explains why issues often recur even when procedures exist, audits pass, and documentation appears complete.
Our work bridges regulatory intent, quality system behavior, and engineering execution to make control visible where it matters most: At the point of decision. By identifying where signals break down or arrive too late, DocuRegs helps organizations move from reactive correction to predictable system behavior.
The objective is not faster documentation or short-term fixes, but integrated control built into how systems operate. When control is designed upstream, compliance becomes a natural outcome rather than a recurring effort.
DocuRegs provides structured thinking, practical frameworks, and clarity for MedTech teams seeking durable control, consistent decision-making, and outcomes that hold as complexity increases.
Integrated Control Diagnostic™ - System Foundations
Integrated Control Diagnostic™ - Governance and Oversight
Management Review Isn't a Meeting - It's a Control Mechanism
AI in MedTech: Integrating Intelligence Into Control Systems
Integrated Control Diagnostic™ - System Foundations