Bridging Regulatory, Quality, and Engineering

Welcome to DocuRegs — Bridging Regulatory, Quality, and Engineering in MedTech

At DocuRegs, we help medical device professionals simplify complex compliance challenges- whether you're working toward EU MDR technical documentation, UKCA MHRA marking, FDA 510k submission, Health Canada MDL, or aligning your product with ASEAN medical device requirements.

As the sister company of MedicalRegs (est. 2017), DocuRegs offers a one-stop resource hub where regulatory affairs, quality assurance, and medical device engineering come together to accelerate market access without the jargon, confusion, or wasted time.

Whether you're launching a startup or scaling global submissions, we’ve built practical tools designed to support your success across every stage:

📚 E-books filled with actionable insights on topics like technical documentation, UDI, IEC60601, and regulatory strategy
🎓 Online courses designed for MedTech professionals steering the global regulatory frameworks
📂 Downloadable templates to streamline your documentation for FDA 510k submission, CE Marking, or QMS audits
🧩 Custom training and workshops for RA/QA teams, product engineers, and regulatory consultants

From SaMD to surgical robotics, we help you connect innovation with compliance so you can design confidently, meet international standards, and get to market faster.

Michael Wetherington is the founder of MedicalRegs and DocuRegs, and author of publications. With over 30 years of experience in regulatory affairs, quality assurance, product certification, and medical device engineering, Michael helps innovative products navigate complex global regulations and reach market efficiently.

His career spans the full MedTech ecosystem—from accredited testing labs and notified bodies to R&D-driven companies—supporting certifications for a wide range of technologies, from non-active devices to advanced systems like surgical saws and rapid infusion pumps.

Michael has a special passion for medical robotics, and actively supports startups and established firms working through FDA, EU MDR, UKCA, and ASEAN frameworks without compromising innovation.

Beyond MedTech, he brings entrepreneurial experience in industries like hospitality, entertainment, product testing, and e-commerce, giving him unique insight into the business challenges startups face. A dedicated mentor and leader, Michael combines deep regulatory knowledge with real-world perspective—bridging compliance and innovation across today’s dynamic medical device space.

• 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