Bridging Regulatory, Quality, and Engineering

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 20 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 the design of systems that produce predictable, controllable results over time.

His career spans the full MedTech ecosystem, including accredited testing laboratories, notified bodies, and R&D-driven manufacturers, supporting technologies ranging from non-active medical devices to advanced systems such as surgical saws and rapid infusion pumps. This cross-functional exposure informs his perspective on why issues recur even in compliant environments, and how design, decision-making, and feedback loops shape regulatory and quality outcomes.

Michael has a particular interest in medical robotics and complex systems, and actively supports organizations working within FDA, EU MDR, UKCA, and ASEAN frameworks while preserving engineering intent and innovation.

His approach emphasizes alignment between regulatory intent, quality system behavior, and engineering execution especially as products and organizations scale.

Beyond MedTech, Michael brings entrepreneurial experience across industries including hospitality, entertainment, product testing, and e-commerce. This broader business background informs his systems-level perspective on growth, risk, and organizational behavior, allowing him to bridge compliance requirements with real operational realities.

Through DocuRegs, Michael provides structured thinking, frameworks, and perspective for teams seeking not just approval or compliance, but durable control built into the way their systems operate.

• Michael was featured in the MedTech Leading Voices (MLV) Yearbook 2025, a publication that spotlights industry leaders driving progress in MedTech. This recognition reflects his longstanding dedication to  regulatory excellence, mentorship, and thought leadership within the RA/QA community. 

• "We hired Michael as our Regulatory Specialist to undertake due diligence tasks and regulatory assessments across our many e-commerce brands. He has done so professionally and accurately across cosmetic products, medical devices, and drug products. Thanks, Michael!" Sachin S. - Co-Founder and  President

• "Mike is a Global Regulatory Guru. He is professional and very helpful person. It is a pleasure and honor to recommend Mike." Vartan C. - Sr. Director Of Global Compliance Regulatory, Safety, and Sustainability 

• "Mike is a HUGE asset in navigating the world of medical device regulations and best practices. Even between larger projects he continues to support with additional resources and guidance. I highly recommend him for regulatory support in this complex field for any project, large or small."  Eric C. - Director, Global Product Regulatory and Compliance

• "Michael has been our consultant through our ISO13485 certification project. Michael has been there to guide us through the process, a constant reference with his extensive knowledge, and advice, both in relation to the minefield of regulations and ensuring our QMS was fully compliant in line with our notified body's requirements. Thanks Michael!" Simon M. - Operations Director