Claus Svane Soendergaard, Ph.D.

Claus Svane Soendergaard, Ph.D.

Associate Director, Biocompatibility

Dr. Soendergaard brings over 15 years of valuable expertise in biomedical and medical device research and development, gained through leadership positions in both academic and industrial settings. His comprehensive work spans various domains, including cardiovascular diseases, soft tissue repair, and wound care, with specialized proficiency in stem cells, tissue engineering, and regenerative medicine. Dr. Soendergaard has conducted extensive in vitro and in vivo pre-clinical research, focusing on the advancement of medical devices, cellular- and tissue-based products, HCT/Ps, as well as combination products. His contributions have been documented in numerous peer-reviewed scientific papers and patents on biomaterials, both in the United States and internationally. Furthermore, Dr. Soendergaard possesses significant expertise in biocompatibility assessment and biological risk evaluation. He has played a pivotal role in supporting successful regulatory filings for various products, ensuring compliance with regulatory standards in the US, EU, China, Japan, and other key markets. Additionally, Dr. Soendergaard has in-depth experience working with biomaterials derived from animals and holds unique knowledge in viral inactivation validation and surveillance of zoonotic risks, particularly in alignment with ISO22442-compliant materials and devices.


Dr. Soendergaard holds a Master of Science in Molecular and Cellular Biology and a PhD in Medicine for Aarhus University in Denmark and well as a Certificate Degree in Biotechnology Project Management for University of Washington and Biocompatibility Certifications from NAMSA.


Dr. Soendergaard joined MCRA in August 2022, bringing with him a wealth of experience in the biomedical industry. Prior to joining MCRA, he served as the Manager of Discovery and Biosciences at Cook Biotech Inc., where he successfully led a diverse team comprising scientists, engineers, and technicians. Under his guidance, the team was actively involved in the development of cutting-edge technology platforms, while also managing biocompatibility and biological risk assessment initiatives. Dr. Soendergaard's contributions at Cook Biotech played a crucial role in supporting numerous products in various therapeutic areas. Before his tenure at Cook Biotech, Dr. Soendergaard held the position of Assistant Professor of Surgery at the Division of Cardiothoracic Surgery and the UC Davis Medical Center in Sacramento where he focused on pioneering regenerative therapies targeting cardiovascular and neurological diseases. At UC Davis, Dr. Soendergaard successfully secured and managed numerous multi-million-dollar grants, and his research findings were published in highly respected, peer-reviewed scientific journals.


Dr. Soendergaard is a highly accomplished scientist with multiple peer reviewed publications, research grants, patents, and presentations at international meeting. His combined background in industry and academia gives him a unique perspective from the client’s point of view and he is acutely aware of the many challenges and constraints clients are constantly faced with in bringing and keeping new products on the market.

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