Niki Caporali-Spaniel is Co-Founder of indieMedTech. With more than 20 years of experience in regulatory, quality, and clinical affairs, Niki has led global strategies spanning the full medical device lifecycle, from early development through post-market evidence generation. She has successfully navigated complex submission pathways in the U.S., Europe, and Canada, including FDA 510(k), De Novo, IDE, PMA supplements, and Emergency Use Authorizations, as well as EU MDR technical and clinical documentation and Health Canada licensing.
Her expertise spans a wide range of technologies including cardiovascular devices, surgical robotics, orthopedics, women’s health products, diagnostics, biologics, and combination products. Niki has designed and remediated quality management systems, conducted risk management in alignment with ISO 14971, performed usability engineering and human factors studies, developed clinical evaluation and post-market surveillance programs, and spearheaded more than 80 PMCF initiatives to support EU MDR compliance. She also brings deep experience with specialized areas such as home-use products, Rx-to-OTC transitions, and pediatric devices.
Known for her collaborative leadership, empathy, and practical, business-balanced approach, Niki has supported companies of all sizes, from early-stage startups to global manufacturers serving as both technical advisor and regulatory correspondent in high-stakes submissions. Beyond her technical expertise, she is recognized for the meaningful, long-term relationships she builds with clients and colleagues, grounded in trust, clear communication, and a genuine commitment to shared success. A sought-after subject matter expert, Niki has delivered webinars, training programs, and executive workshops on regulatory and clinical strategy, inspiring teams while guiding them through the complexities of global compliance.
