Dr. Jan Havel is Global Director at TÜV SÜD Product Service, leading an international team of experts specializing in sterilization, packaging design, sterile barrier systems, packaging process validation, reprocessing validation for medical devices, and the biological and microbiological safety of healthcare products. He has been working as an expert within the notified body environment since 2007, supporting manufacturers in meeting regulatory and quality requirements for medical devices. In addition to his leadership role, Dr. Havel is an experienced trainer and speaker on sterilization, packaging validation, risk management, and usability engineering. He has actively contributed to international standardization efforts, including participation in ASTM F02 on Primary Barrier Packaging. Through his extensive expertise in regulatory assessment and standards development, he supports the advancement of safe, effective, and compliant medical technologies worldwide.