Bridging Regulatory, Quality, and Engineering with Decision Engines
Designing systems where compliance emerges from integrated control.
Purpose-Built Regulatory Decision Engines™
Regulatory Product Classification Engine™
Regulatory Product Classification Engine™
Regulatory Product Classification Engine™
RPCE provides a structured, evidence-based assessment to help determine whether a product aligns with an FDA Medical Device, Drug, Cosmetic, Food, or Dietary Supplement classification. Evaluate the product based on its intended use, claims, characteristics, and supporting information - not assumptions alone.
Regulatory Market Entry Engine™
Regulatory Product Classification Engine™
Regulatory Product Classification Engine™
RMEE helps identify the U.S. regulatory pathways and market-entry requirements that may apply to your product. Evaluate product, manufacturer, claims, technology, market, and import information to understand what may apply, what remains unresolved, and what to address next.
Regulatory Standards & Testing Engine™
Regulatory Product Classification Engine™
Medical Device Risk Classification Engine™
Determine What Standards Apply. Plan What Comes Next.
RSTE is being developed to help medical device teams identify applicable standards, testing and evaluation activities, and the planning artifacts needed to support compliance.
Using product characteristics, technology, intended use, and other relevant inputs, RSTE will help teams understand what may apply, why it applies, what evidence may be needed, and what to plan for next.
Medical Device Risk Classification Engine™
Medical Device Risk Classification Engine™
Medical Device Risk Classification Engine™
Medical Device Risk Classification Engine™ (MDRCE)
COMING SOON
Determine Your Medical Device Risk Classification
MDRCE is being developed to help medical device and IVD teams determine the applicable risk classification for their products in the U.S. and European Union.
Using device characteristics, intended use, technology, patient interaction, and other jurisdiction-relevant inputs, MDRCE will provide structured, evidence-based classification support with clear reasoning and appropriate next steps for U.S. and EU regulatory pathways.
Coming Soon
Quality Event Decision Engine™ (QEDE)
Medical Device Risk Classification Engine™
Quality Event Decision Engine™ (QEDE)
Quality Event Decision Engine™ (QEDE)
COMING SOON
Turn Quality Events Into Clear, Defensible Decisions
QEDE is being developed to help quality and regulatory teams consistently evaluate quality events, determine appropriate actions, and document the rationale behind critical decisions.
Using structured event information, risk considerations, regulatory impact, and other relevant inputs, QEDE will guide teams through a governed decision process to support appropriate quality actions, regulatory considerations, investigations, and documented outcomes.
Coming Soon
Our Integrated Control Flagship Collection & RA/QA/Engineering Services
AI Documentation Assurance™
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𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 𝗥𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 Consulting
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This is a complimentary e-booklet.
This is a complimentary e-booklet
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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, real estate, entertainment, product testing lab, 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.