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.

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.

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.

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.

*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 am the Chief Medical Officer at Boomerang Health Care, a state of the art multidisciplinary specialty group offering interventional, surgical and rehabilitative care through its 25 clinics in California. I also serve as the Medical Director at Le Reve: Regen, a leader in cutting edge restorative and regenerative solutions for Spine, Orthopedics and Musculoskeletal conditions. In the academic world, I have served as a Clinical Faculty at Stanford University for more than 20 years and have established myself as a world leader in cutting edge innovative therapeutic solutions. I completed her Anesthesiology residency from Medical College of Wisconsin, Milwaukee and Fellowship in Pain Medicine from the University of California, Davis. I am board certified in Anesthesiology and Pain Medicine by American Board of Anesthesiology, in Interventional Pain by American Board of Interventional Pain Physicians and in Regenerative Medicine by American Board of Regenerative Medicine. I sit on the Editorial board of the journal, Pain Physician and serve on the board of the American Society of Interventional Pain Physicians, Latin American Pain Society, California Society of Industrial Medicine and Surgery, California Society of Interventional Pain Physicians and Scilex (Nasdaq: SCLX). I am humbled to receive the Distinguished Service Award, Outstanding Achievement Awards and other accolades. I have devoted my entire career to the field of Interventional spine and Regenerative medicine and have contributed via several peer reviewed journal articles, visionary editorials, and book chapters. My book, “Essentials of Regenerative Medicine” is first in its right illustrating latest interventional biologic techniques for spine and musculoskeletal injuries. I have also authored several National Guidelines including the ones on Opioids, Interventional Spine Epidural procedures, Facet joints, and the first ever on the Safe and Effective use of Biologics in Lumbar spine. I have completed the first prospective, multicenter, randomized placebo controlled trial demonstrating efficacy of platelet rich plasma and bone marrow concentrate in patients with back pain related to disc injury/degeneration. I consider myself an authority on global health care trends including digital health, technology innovations and applied biologics. Let’s connect and work together to make healthcare better, faster, and more effective – www.annunavani.com.

James Economides, MD, FACS, is a board-certified plastic surgeon in the Washington, DC / Northern Virginia area with a practice focused on advanced facial rejuvenation, breast surgery, and body contouring. He is particularly known for deep-plane facelift and neck lift techniques, mommy makeovers, breast augmentation and revision surgery, and abdominoplasty for post-pregnancy and weight-loss patients. Dr. Economides combines high-volume, real-world clinical experience with an academic mindset—regularly teaching, lecturing, and mentoring trainees—giving him a balanced perspective on both cutting-edge techniques and long-term outcomes. He has been recognized repeatedly as a “Top Doctor” by multiple regional publications, and his practice attracts patients from across the Mid-Atlantic and beyond. In addition to surgery, Dr. Economides has a strong interest in medical aesthetics, non-surgical facial rejuvenation (Botox, fillers, biostimulatory injectables), and the responsible use of artificial intelligence in plastic surgery—from patient education and photography to ethics in before-and-after imaging. As a private practice owner, he also speaks to topics like running a modern aesthetic practice, patient experience, social media, and small-business leadership in healthcare. He is frequently sought out for clear, practical explanations of complex procedures, trends, and controversies in cosmetic surgery. His quotes are concise, patient-centered, and media-friendly, making him a reliable expert source for consumer outlets, health reporters, and business publications covering aesthetics, entrepreneurship, and innovation in medicine.

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.

Dr. Pouyan Golshani is an interventional radiologist and entrepreneur working at the crossroads of healthcare, technology, and finance. He founded GigHz, the hub where he builds and advises across these domains; RadReport AI, an AI-driven radiology reporting engine that turns dictation into structured, clinically-sound reports; Repit.org, a national real-estate intelligence platform exposing ZIP-level trends, rent trajectories, and investability metrics; and Guide.MD, a physician-first directory designed to fix and control online identity without the usual pain. After nearly two decades in medicine and years of hands-on investing, he’s become a go-to voice for clinicians, founders, and investors who want clear, practical explanations of med-tech innovation, AI in healthcare, real-asset strategy, and tax-efficient decision-making. His work blends clinical judgment with a grounded business lens, giving people accurate, no-nonsense insight without oversimplifying anything. He routinely advises early-stage teams, physicians, and allocators on licensing, diligence, and deal structure — with an emphasis on transparency, strong incentives, and long-term value over hype. The goal is simple: help smart people make better decisions in a system that gets more complex every year.

Mr. Ivo Dukic is a leading authority on the intersection of high-volume surgical excellence and digital health transformation. As a Consultant Urological Surgeon and the Deputy Chief Clinical Information Officer (CCIO) at one of the UK’s largest NHS Trusts, he offers journalists a rare perspective that combines frontline clinical mastery with executive-level healthcare technology strategy. Key Areas of Expertise Digital Health & Informatics: Over a decade of experience as the Section Editor of the Digital Review for Urology News (since 2013). He is a specialist in the implementation of health tech within the NHS, clinical informatics, and the evolution of digital tools in specialty care. Surgical Innovation: A pioneer in minimally invasive endourology, specifically in the use of laser technology and "ultra-mini" PCNL for kidney stones. Future Tech in Healthcare: Expert commentary on emerging technologies, including Virtual Reality (VR) in clinical settings (as featured on ITV News) and the integration of advanced medical devices. Clinical Leadership: Former Educational Lead for Urology and the 2025-2026 West Midlands Urology Trainer of the Year, providing deep insights into medical education and workforce development. Media Experience Mr. Dukic is an accomplished communicator, comfortable translating complex surgical and technical data into compelling narratives for the public and the profession: Television: Featured on ITV News discussing the use of distraction VR during lithotripsy. Consumer Health: Expert contributor for BBC Good Food on dietary health and stone prevention. Trade Press: A decade-long track record of technical writing and editorial leadership regarding the "Digital Review" in urology.

I am a thought leader and have a passion in making an impact in creating solutions to today's obesity epidemic.

Dr. Francisco Agullo, known to many patients and peers as Dr. WorldWide, is a board-certified plastic surgeon recognized for his expertise in advanced aesthetic and reconstructive procedures. Certified by both the American Board of Plastic Surgery and the American Board of Surgery, he brings a comprehensive and highly refined approach to patient care, combining surgical precision with a deep understanding of form, function, and long-term outcomes. Dr. Agullo completed his plastic surgery training at the Mayo Clinic in Rochester, Minnesota, one of the most respected medical institutions in the world. He currently serves as a Clinical Assistant Professor at Texas Tech University Health Sciences Center, where he contributes to the education and mentorship of future surgeons while remaining actively engaged in academic and clinical advancements. Based in El Paso, Texas, Dr. Agullo serves a diverse patient population across West Texas, New Mexico, and Northern Mexico, with a large percentage of patients traveling from across the United States and internationally. His practice is known for delivering high-level, personalized care supported by a well-coordinated team that prioritizes safety, efficiency, and a seamless patient experience. His clinical interests include facial rejuvenation, breast surgery, and body contouring, with particular emphasis on preservation techniques that maintain natural anatomy while enhancing aesthetic outcomes. He is recognized for incorporating innovative technologies and techniques such as deep plane facial surgery, advanced liposculpture, and preservation-based breast augmentation. His philosophy centers on providing patients with clear, honest guidance, ensuring they are fully informed and empowered to make the best decisions for themselves. Dr. Agullo has been consistently recognized for excellence in his field, earning distinctions such as Texas Super Doctors and Castle Connolly Top Doctor for over a decade. His work has also been featured in national publications and industry platforms, reflecting both peer recognition and patient satisfaction. Through his clinical work, academic involvement, and commitment to innovation, Dr. Agullo continues to contribute meaningfully to the evolution of modern aesthetic surgery while maintaining a strong focus on individualized patient care and long-term results.

Carmen M Lerga is a cosmetic scientist and regulatory expert with three decades of experience shaping successful beauty and skincare products for global brands including Dove, Rexona, Axe, Isdin, Covonia, Oilatum, Cetraben, Hedrin, Nizoral, and INEOS. She leads Olalla Consulting, a consultancy recognised for scientific rigor, clarity, and deep knowledge of EU and UK cosmetic regulation. Her background spans formulation development, global regulatory leadership, ingredient safety assessment, and the creation of clear and balanced scientific narratives for brands and manufacturers. Carmen specialises in well aging science, neuro skin communication, and microbiome stability, bringing an evidence based perspective to emerging trends and product innovation. Journalists value her ability to explain complex topics in a straightforward and non promotional way. She offers grounded insights into regulatory changes, ingredient safety, formulation strategy, and the science behind modern beauty innovation. Her work supports companies seeking transparent, compliant, and science led product development across Europe and beyond.