Holger Wagner

Head of Regulatory Affairs - Business Unit Hospital Consumables & Accessories, Medical Division at Drägerwerk AG & Co. KGaA

Speaker

Holger Wagner brings over 17 years of expertise in medical technology to his role as Chairman of the U.S. Workshop at the MedTech Summit 2025 in Berlin. As Head of Regulatory Affairs for Dräger’s Hospital Consumables and Accessories (HCA) Business Unit, he oversees a portfolio of more than 2,500 medical devices, ensuring compliance and fostering innovation across global markets. Under his leadership, Dräger increased U.S. FDA 510(k) submissions up to 300% between 2022 and 2024, achieving a 100% acceptance rate—a reflection of his exceptional ability to navigate complex regulatory frameworks.

Wagner’s career includes key roles such as development engineer at Retina Implant AG and Lead Auditor at TÜV Süd, where he conducted global audits under MDD, MDR, MDSAP, and ISO 9001 standards. His innovative application of TRIZ (Theory of Inventive Problem Solving) resulted in US-9566427-B2, a patented electrostimulation device now used in over 50 clinics worldwide. At Dräger, he led the successful transition of the HCA portfolio to MDR compliance ahead of deadlines and initiated the “Empowered Local RA” project, reducing approval times for over 700 products in ASEAN.

Recognized as a leader in regulatory affairs, Wagner has influenced industry practices through cross-functional collaboration and process optimization. With a strong foundation in engineering and quality management, he continues to advance patient safety and technological excellence on an international scale.