Bridging Regulatory, Quality, and Engineering Through 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 Products & 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
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Our Founder and CEO
Michael Wetherington is the founder and CEO of DocuRegs® and the author of multiple publications focused on regulatory affairs, quality, engineering, and systems behavior in MedTech.
With more than 25 years of experience spanning regulatory affairs, quality systems, product certification, testing, and medical device engineering, Michael has worked across much of the MedTech ecosystem—from accredited testing laboratories and notified bodies to R&D-driven manufacturers.
His experience includes technologies ranging from non-active medical devices to complex systems such as rapid infusion pumps and emerging robotic platforms, as well as supporting organizations operating within FDA, EU MDR, UKCA, and ASEAN regulatory frameworks.
Throughout his career, one recurring challenge has shaped his approach: critical regulatory, quality, and engineering decisions are often made across organizational boundaries, using fragmented information, disconnected processes, and expertise that can be difficult to translate consistently into action.
That insight helped shape the evolution of DocuRegs.
Today, DocuRegs develops Decision Engines™ designed to bring greater structure, consistency, transparency, and explainability to complex regulatory, quality, and engineering decisions.
Rather than treating regulatory approval, quality outcomes, or engineering compliance as isolated objectives, Michael's approach focuses on the interactions between regulatory intent, quality-system behavior, engineering execution, and the decisions connecting them.
This philosophy is reflected in the DocuRegs mission:
Bridging Regulatory, Quality, and Engineering Through Decision Engines™
The objective is not to replace professional expertise, but to make critical decision processes more structured, explainable, reproducible, and actionable—helping organizations identify what matters, understand why it matters, and determine what to address next.
About Us
DocuRegs® develops Decision Engines™ that bring structure, consistency, and explainability to complex regulatory, quality, and engineering decisions.
Our approach is grounded in how regulatory, quality, and engineering systems actually behave in practice—particularly as organizations scale, products become more complex, requirements evolve, and critical decisions cross functional boundaries.
Rather than treating compliance as a checklist or regulatory, quality, and engineering activities as separate disciplines, DocuRegs focuses on the decisions, evidence, handoffs, and feedback loops that connect them. These are often the points where control is established, maintained or lost.
This systems perspective shapes the DocuRegs Decision Engines™. Each engine is designed around a specific decision problem, transforming relevant inputs and governed logic into structured, explainable, and actionable decision support.
Across product classification, medical device risk classification, market entry, standards and testing, quality events, and future applications, the objective remains consistent: help users understand what matters, why it matters, what remains unresolved, and what to address next.
Technology does not eliminate the need for professional expertise. It can, however, make critical decision processes more consistent, transparent, reproducible, and easier to act upon.
By bringing regulatory intent, quality-system behavior, and engineering execution together at the point of decision, DocuRegs is building toward a broader vision:
Bridging Regulatory, Quality, and Engineering Through Decision Engines™
Better decisions upstream. Greater control downstream.