Dr. Rohit Thanki is a Senior AI Researcher and Data Scientist with over fifteen years of academic and industry research experience, and more than eight years specifically focused on AI-powered medical technologies. He is currently based in Wolfsburg, Germany, where he develops and leads regulatory-compliant AI solutions for healthcare diagnostics, medical image analysis, and clinical decision support. His work spans multiple domains including cancer diagnostics, orthopaedic rehabilitation, signal processing, and Software as a Medical Device (SaMD) development. Dr. Thanki has held key positions in AI R&D leadership, including as Head of Research and Development at Prognica Labs in Dubai, where he spearheaded AI-based breast cancer screening technologies, and as a Senior Data Scientist at KRiAN GmbH in Germany, focusing on AI for orthopaedic diagnostics & rehabilitation. His work involves the end-to-end development of machine learning and computer vision models, including their validation under international regulatory frameworks such as CE marking, ISO 13485, and ISO 62304. In addition to his industrial roles, he serves as an active academic supervisor, currently guiding Ph.D. research in AI and medical imaging, and mentoring thesis projects at German and Indian universities. An accomplished author and researcher, Dr. Thanki has published over 100 Scopus-indexed research papers and more than 50 articles in Web of Science–indexed journals. He has also written or co-authored over 25 academic books with leading publishers such as Springer Nature, CRC Press, and Elsevier. His books cover key areas, including AI in cancer diagnosis, medical image security, the Internet of Medical Things (IoMT), and explainable AI in medicine. Several of his publications are part of prestigious Springer series including SpringerBriefs in Electrical and Computer Engineering, Signals and Communication Technology, and Biomedical Engineering. His contributions have been widely recognized: he was honored with the Transformational Leadership Award in 2021 (Dubai) for the best deployment of machine learning in healthcare, and he has received multiple Best Paper awards in international conferences. As a recognized thought leader, Dr. Thanki has delivered expert talks and keynote lectures at institutions and international events on topics such as medical image AI, clinical NLP, and SaMD development. He also actively serves as a session chair and technical committee member in global conferences. Dr. Thanki is a Senior Member of IEEE, a member of the German Society for Artificial Intelligence in Medicine, and the German AI Association. He serves on the editorial boards of BMC Digital Health and Humanities and Social Sciences Communications (Springer Nature) and is a frequent reviewer for top-tier journals such as IEEE Transactions on Biomedical and Health Informatics, Elsevier’s Computers in Biology and Medicine, and Springer’s Artificial Intelligence Review. With his deep understanding of both technical AI development and global regulatory landscapes, Dr. Rohit Thanki is uniquely positioned to guide innovators and professionals through the complexities of medical technology (MedTech) compliance. His work bridges science, technology, regulation, and practice, making him an authoritative voice for this practical guide to navigating the MedTech regulatory maze. Dr. Sejal Shah is currently serving as the Associate Professor & Head at Department of Bioinformatics, Faculty of engineering and technology, Marwadi University Rajkot, India. She is also serving as Cancer Geneticist and molecular tumour board member at various multispecialty hospitals In India. She is visiting faculty at IIIT Diu International campus and Saurashtra University. She has been selected in top 10 women scientists and awarded Indo-US women in STEMM fellowship (2019) by DST, Government of India and IUSSTF jointly to pursue post-doctoral research at Ohio state university, USA in paediatric leukaemia. She has been selected among 15 women scientists all over India by DST, KIRAN division for cancer research training organized at Mysore University, Mysore, India in 2018. She has been also awarded “Woman Scientist Fellow” in May 2012, in Women Scientist Scheme-A (DST/ WOS-A) of Department of Science and Technology, New Delhi, Government of India. She has more than 14 years of research experience in the field of cancer omics, biotechnology, nanotechnology and Artificial Intelligence. During this period, she has been involved in teaching and cancer research. She has eight years of teaching experience as well industrial experience such as RK University, Rajkot; Sun pharma industries, Vadodara; and PERD centre, Ahmedabad. She and her team are currently working on oral cancer, cervical cancer and breast cancer. She is associate member of American Association of Cancer Research (AACR) , Life member of European association of cancer research (EACR), scientific decoder at COVID-19 Omics Research Consortium (CORC) and Breast cancer research consortia(BCRC). She has six Indian patents to her credit. She has more than 57 publications with 10 book chapters, 1 Book and eight research projects to her credit from various funding agencies. She is a reviewer in various national/international journals as wells. She is the advisor of IEEE Engineering in medicine and biology (EMBS) student branch chapter, Gujarat. She is an active member of Women in Engineering, Gujarat Section India as well.