Recognized Medical Device Regulatory Experts Leaders 2025

Founder of MDx CRO a specialized clinical research and regulatory consultancy dedicated to the medtech IVD sector. As a seasoned consultant in clinical and regulatory affairs, I am experienced in navigating complex regulatory challenges for top IVD companies. I have the privilege of serving as an external expert for the EU Commission and having lead global regulatory projects at BSI, one of the largest Notified Bodies as an IVDR CE mark technical expert. My portfolio of satisfied clients includes renowned companies such as Biomerieux, Cepheid, Leica (Danaher), Hologic, Grifols, Abbott, Beckman Coulter, ThermoFisher Scientific, Instrumentation Laboratory (Werfen), Roche Diagnostics, Alere, and more. I am passionate about simplifying science and regulation for my clients, delivering tailored solutions that help them stay ahead of the competition. My secret to success is building relationships based on trust, expertise and kindness. My clinical background, combined with 15+ years in the IVD industry and regulatory authorities, makes me a valuable resource for clients of all sizes. Let's connect and find out how I can help you navigate the ever-evolving world of IVD and MedTech 💬

A post-graduate in Pharmaceutics from Mumbai University with over 25 years of Regulatory Affairs experience across leading Pharmaceutical and Medical Device organizations. Managing Regulatory affairs is my core strength and in addition I have a rich experience in handling quality compliance, clinical trials, patents and scientific information. In 2011 I started with my own venture - Regulatory Solutions India for providing Regulatory Affairs consultancy with a motto to build 'bright bRight strategies' to organizations . Regulatory Solutions India provides RA services to the Medical Device/Pharmaceutical/ Cosmetic Industry, which include:1) Regulatory Strategy Development 2) Consultancy services from application submission to Product Approvals/ Licenses comprising:

I’m a lifesciences compliance strategist with a passion for building real-world, right-sized programs in fast-moving environments. With deep experience in pharma and medtech, I specialize in translating regulatory complexity into practical, actionable frameworks. I’ve spent 7+ years navigating the gray areas of compliance—from training physicians on industry expectations to building startup programs from the ground up. I believe compliance should be ethical, functional, and human-centered—and that culture is built through clarity, storytelling, and respect, not fear. Outside of policy and audits, I speak regularly on startup compliance and love turning “boring” topics into memorable moments. I'm here to connect, create, and contribute.

Award-winning enterprise healthcare and medical technology commercial professional with experience driving growth across hospitals, integrated delivery networks (IDNs), ambulatory surgery centers, and complex healthcare systems. Throughout my career, I have partnered with physicians, surgeons, executives, value analysis committees, supply chain leaders, clinical teams, and operational stakeholders to evaluate, implement, and expand medical technologies and capital equipment solutions. My background spans strategic account management, enterprise healthcare sales, capital equipment, medical devices, clinical adoption, commercialization, territory transformation, account expansion, and stakeholder alignment. I have experience navigating the realities of healthcare purchasing, including value analysis review, budget considerations, contracting discussions, implementation planning, workflow integration, utilization growth, and long-term customer success. I regularly work at the intersection of clinical, operational, and commercial priorities, helping healthcare organizations evaluate technology investments while balancing patient outcomes, operational efficiency, financial considerations, physician preferences, and organizational objectives. My experience includes engaging executive leadership, department heads, clinicians, supply chain teams, and cross-functional decision-makers throughout the buying and adoption process. Areas of expertise include healthcare technology, medical devices, capital equipment, hospital purchasing, value analysis, strategic accounts, IDN and health-system growth, healthcare commercialization, physician engagement, clinical education, workflow optimization, implementation readiness, utilization growth, GPO and contracting considerations, proposal development, account governance, customer retention, and enterprise sales strategy. I am particularly interested in providing commentary and insights related to healthcare purchasing trends, hospital buying behavior, medical technology adoption, healthcare commercialization, strategic account management, physician and stakeholder alignment, value analysis committees, capital equipment acquisition, healthcare innovation, and the challenges associated with bringing new technologies into complex healthcare environments.

Hardik Lathiya is a medical device manufacturing and process engineering professional specializing in precision drug-coating technologies for implantable medical devices. His expertise includes ultrasonic spray coating, manufacturing process optimization, design of experiments (DOE), process validation, yield improvement, and quality engineering for regulated medical device manufacturing. His work focuses on bridging product development and scalable manufacturing, improving process reliability, and advancing manufacturing technologies for drug-device combination products.

Biomedical Engineer and MedTech professional with diverse, cross-functional experience across research, engineering, systems, clinical research, project management, quality, and health sensor technologies, building and launching products across robotics, wearables, and therapeutic systems. Actively engaged in mentorship, judging, and professional societies, with a passion for bridging academia, industry, and clinical practice to support inclusive innovation and early-career development.

Senior Compliance Specialist dedicated to bridging the gap between complex regulation and practical engineering. Over a decade of hands-on experience in EMC, Product Safety and Global Market Access. Currently focusing on Cybersecurity.

As I am a medical expert for Invigor Medical, a urologist, and an MD currently completing my PhD in clinical medicine, my work bridges patient care, education, and research. I serve as a teaching assistant in surgery, where I guide and support future doctors while treating patients in everyday practice. My research focuses on oncologic urology, men’s health, and hormonal health, and I actively collaborate on international studies. Through these roles, I am dedicated to advancing evidence-based medicine, improving patient outcomes, and helping shape the future of urological care.

I am a distinguished regulatory strategist with over 20 years of expertise in the pharmaceutical and medical device sectors. As the Principal Consultant at Arora 297 Consultancy, I specializes in guiding international manufacturers through the complex regulatory frameworks of Health Canada and the FDA. With a foundational background in Pharmacy and an MBA, Avinash bridges the gap between technical product specifications and high-level business strategy. His career includes pivotal roles at industry leaders in pharmqaceuitclal industry and Medical Devices industry, where I mastered the nuances of risk governance and inspection readiness. Today, I empowers clients with a "regulatory-first" mindset, ensuring not only market entry but long-term license protection and compliance integrity.

Edmundo A. Rodriguez-Frias, M.D., is a dual-board-certified gastroenterologist and geriatrician with 24 years of experience in internal medicine and 12 years dedicated to caring for patients with digestive health concerns. Currently serving as a medical contributor at The Retreat of Broward, he provides comprehensive, expert care across multiple hospital facilities and clinical locations with clinical affiliations at Anderson Hospital and The Methodist Hospitals Northlake Campus. By specializing across gastroenterology, geriatric medicine, internal medicine, and hospital medicine, Dr. Rodriguez-Frias is uniquely equipped to address the complex medical needs that often arise as patients age. He earned his medical degree from the Universidad Peruana Cayetano Heredia (Facultad De Medicina Alberto Hurtado) in Lima, Peru, before completing an Internal Medicine internship at UT Memphis and an Internal Medicine residency at UT Southwestern. He further advanced his training through a Geriatrics Fellowship at the Baylor College of Medicine and a Gastroenterology Fellowship at the University of Louisville. His extensive clinical background also includes serving as a hospitalist and gastroenterologist at Alton Memorial Hospital and practicing gastroenterology at Carlinville Area Hospital and HSH St. John's. An active member of premier professional organizations such as the AGA, ASGE, AASLD, ACP, AMA, and the Peruvian College of Physicians, he has also served as a journal reviewer for Academic Medicine Journal and Annals of Internal Medicine, and was included in the 2011 edition of Marquis Who’s Who in the World. Dr. Rodriguez-Frias is an accomplished researcher whose work has been featured in publications like Clinical Gastroenterology and Hepatology, Digestive Diseases and Science, Gastrointestinal Endoscopy, and Clinics in Liver Disease, and he collaborated on the textbook Gastroparesis: Current Opinions and New Endoscopic Therapies. He has presented numerous research posters at major medical conferences, including earning a "Poster of Distinction" at Digestive Disease Week in 2008.

RERA360 is a specialized real estate compliance and advisory firm focused exclusively on the Real Estate (Regulation and Development) Act, 2016 (RERA). The organization supports builders, developers, real estate agents, and homebuyers by simplifying complex regulatory requirements and ensuring end-to-end compliance across real estate projects. With a strong understanding of RERA frameworks, state authority processes, and evolving regulatory guidelines, RERA360 delivers structured, accurate, and timely compliance solutions. Its services cover project registration, quarterly and annual filings, documentation management, authority coordination, and advisory support—helping stakeholders operate with transparency, accountability, and legal certainty. RERA360’s approach is built on clarity, process discipline, and practical execution. By reducing compliance risks and administrative burdens, the firm enables real estate professionals to focus on project delivery, credibility, and long-term growth while remaining fully aligned with regulatory obligations. The mission of RERA360 is to strengthen trust in the real estate ecosystem by making compliance simple, accessible, and reliable—transforming regulatory requirements from obstacles into operational advantages.

Dr. Pietro Emanuele Garbelli (“Dr Garbelli”) is a UK-based physician, healthcare strategist and MedTech advisor focused on assisting healthcare leaders and organisations adopt, navigate, and implement AI/robotics and healthcare automation safely, ethically and at scale. Working at the intersection of clinical practice, technology and executive decision-making, he supports boards, executive teams and MedTech leaders to turn innovation into measurable improvements in patient outcomes, workforce sustainability and operational performance. Dr Garbelli is the creator of the Healthcare Convergence Framework™ (HCF), a practical approach that helps organisations assess AI/Robotics readiness, align leadership priorities and design future-ready care pathways without disrupting frontline delivery. His work typically spans AI and robotics strategy, governance and risk management, clinical adoption and change leadership—ensuring that new technologies strengthen trust, accountability and safety in real-world conditions. As a keynote speaker and author, Dr Garbelli translates complex topics such as AI governance, clinical safety, ethics and system transformation into clear, actionable insights for senior audiences. He is the author of The Doctor’s Future and The Doctor’s Voice, and contributes thought leadership on how medicine is being reshaped by digital transformation and emerging technologies. Known for a pragmatic, clinician-led perspective, Dr Garbelli helps leaders navigate high-stakes decisions such as build-versus-buy, pilot design, evaluation and scaling across multiple sites. His mission is to purposefully transform the future of medicine—one organisation, strategy and physician at a time—with confidence.

As a Diagnostic Radiologist and Postgraduate Medical Professor, I provide journalists and media outlets with highly accurate, evidence-based medical analysis. I am a contributing author to major Brazilian media platforms, having published full-length medical articles in tier-one outlets including CNN Brasil, Veja Saúde, SBT News, Portal Jovem Pan, and Brazil Health. My primary expertise lies in diagnostic imaging and translating complex scientific data into clear, accessible public health information. I hold a medical degree from Universidade Luterana do Brasil and actively practice in clinical diagnostics and academic education. Furthermore, I am the published author of the books "Decifre Sua Saúde" and "Perimenopausa Desmistificada", and the creator of the health literacy platform @drexplicaoficial. Backed by a clinical track record of over 170,000 completed diagnoses in radiology and diagnostic imaging, I am available to provide expert quotes, interviews, and detailed commentary on medical examinations (both imaging and general), clinical diagnostics, and broad health topics, including general health. My dual background in rigorous clinical practice and direct digital communication allows me to deliver precise medical insights in a format ready for broad media consumption.

Dr. Chantal Lunderville, MD is a UCSF-trained family medicine physician and nationally recognized expert in medical wellness, aesthetics, compliance, and practice growth. She serves as the Medical Wellness Editor for Lipgloss and Aftershave, a leading spa industry publication with a reach of more than 250,000 readers and followers. She has been mentioned in Forbes, and she has been a featured speaker for global brands including L’Oréal and Epicutis. As the medical director for 20+ aesthetic and wellness practices across California, Dr. Lunderville specializes in helping doctors, nurses, and entrepreneurs build safe, compliant, and scalable practices. She and her team have developed proprietary software that enables medspas to track compliance, medical director oversight, and regulatory requirements- now being made available to the public to elevate industry standards. She has also hosted large-scale women's wellness events and professional trainings with sponsors such as goop Kitchen, AQ Solutions, UnderSkin, South Coast Psychiatry, and Reproductive Partners. A former medical spa owner turned national consultant, Dr. Lunderville empowers women in aesthetics to build legacy-driven, ethical businesses. She is also a leader in longevity and preventive wellness, blending evidence-based lifestyle wellness with advanced regenerative treatments. She is also an aesthetic and womens health trainer focusing on new practitioners. Dr. Lunderville is available for expert commentary on aesthetics, medical wellness, compliance, women’s entrepreneurship, and the future of longevity medicine.

As a Mold Making and Precision Manufacturing Expert with over 10 years of hands-on industry experience, I specialize in advanced injection molding technologies, rapid prototyping, and scalable end-to-end manufacturing solutions at First Mold (www.firstmold.com). Beyond the shop floor, I am actively engaged in industry thought leadership and technical communication. I regularly author in-depth, data-driven articles on modern manufacturing trends and DFM (design for manufacturability) optimization for our company platform, while also curating a dedicated professional Newsletter on LinkedIn for nearly 1,000 engineering and industry peers. Throughout my career, I have worked closely with global brands to streamline production cycles and solve complex engineering challenges. I bridge the gap between initial design concepts and high-volume, cost-effective production, ensuring strict quality control every step of the way. For journalists, media professionals, and industry peers seeking practical, field-tested insights on tool design, manufacturing innovations, and supply chain trends, I am always open to sharing expert commentary and data-backed perspectives.

Co-founder and CEO of Sequenex, an ISO 13485-certified software product development firm. We build regulated software for medical device companies: Software as a Medical Device (SaMD), wearables, biosensors, CGM and insulin pumps, and connected device platforms for remote and therapeutic monitoring (RPM and RTM). What separates us is what our customers walk away with. They own the source code, the platform, and the infrastructure it runs on. No lock-in. We work with device companies from early feasibility through Clinical and Commercial milestones, developing the software and its supporting evidence together, so the next milestone is a step forward rather than a remediation project.

*Board-Certified Family Medicine Physician (ABFM) with 14+ years clinical experience (based in Chicago, IL) *Named Castle Connolly Top Doctor (2024, 2025) *Medical Media Commentator seen on/in ABC 7, Fox 32, CBS 2, WGN 9, The Chicago Tribune , Chicago Sun Times, and Everyday Health; including a nationwide 25 interview satellite media tour (TV & radio, November 2025) *Premedical Student Mentor, Urban Bridges Medical Mentoring Program Dr. Rene is a board-certified Family Medicine physician and Fellow of the American Academy of Family Physicians (FAAFP) with 14+ years of clinical experience. She provides comprehensive primary care for Medicare-eligible patients at Oak Street Health's Avalon Park location in Chicago, specializing in chronic disease management, preventive care, healthcare equity, and access for underserved communities. After overcoming 50 medical school rejections, Dr. Rene graduated from Indiana University School of Medicine and completed residency training at Ascension Saint Joseph Hospital - Chicago. She developed the L.Y.M.I.T.S. Method—a framework for transforming limitations into your greatest strengths. She mentors aspiring physicians through the Urban Bridges Medical Mentoring Program. Dr. Rene has appeared as a medical expert on ABC 7, Fox 32, CBS 2, and WGN 9 Chicago and recently completed a 25-interview national satellite media tour. She is available for expert commentary on resilience in healthcare, medical education equity, resilience and overcoming failure, healthcare access for underserved populations, and diversity in medicine.

Creative marketer and branding strategist with years of experience in professional services environment. Strong strategic planning, project management, client management, public relations and business development skills. Talented client and relationship manager. Advocate for Diversity, Equity and Inclusion programs. Excellent communication, interpersonal, and problem solving skills. Proven ability to work in both independent and team environments. Specialties: Business Development, Communications, Public Relations, Media Relations, Social Media, Relationship Management, Diversity & Inclusion Programs

I'm Eric Franco-Velez, an operations and manufacturing quality professional with 25+ years of hands-on experience in heavy industrial environments — including coatings, fabrication, metal processing, and industrial manufacturing operations. Credentials: AMPP Senior Coatings Specialist | ISO 9001 Certified Internal Auditor | Six Sigma Green Belt | Operations Manager Areas of expertise: ISO 9001 quality management systems — implementation, internal auditing, certification preparation, and clause-level requirements ISO 14001 environmental management — including the April 2026 revision (ISO 14001:2026) and transition requirements ISO 45001 occupational health and safety management — alignment with OSHA 29 CFR requirements in manufacturing IATF 16949 automotive quality management ISO 13485 medical device quality management systems and FDA QMSR transition OSHA compliance for manufacturing and industrial operations ANSI and industry-specific standards for fabrication, welding, and heavy industrial work Environmental compliance — VOC emissions, hazardous waste management, spill containment, wastewater, stormwater Special process documentation — welding, coating, heat treat Supplier quality management and Tier 1/Tier 2 supply chain compliance ISO certification cost, timeline, and audit preparation About The Standards Navigator: I'm the founder of The Standards Navigator (thestandardsnavigator.com) — an ISO and industrial compliance resource site serving quality managers, EHS coordinators, operations directors, and compliance professionals across manufacturing and medical device industries. The site publishes practitioner-focused guides on ISO 9001, ISO 14001, ISO 45001, ISO 13485, IATF 16949, and related standards — written from the perspective of someone who has managed these systems in real manufacturing environments, not from a consulting or academic background. I'm available for expert commentary, source quotes, and contributed content on ISO standards, manufacturing compliance, environmental management, occupational safety, and industrial quality systems.