Leif E. Olsen

Leif Olsen assists clients throughout the life cycle of medical device and diagnostic product development in assessing FDA quality system regulation (QSR) requirements and implementation of post-marketing strategies.

He assists clients in achieving and maintaining compliance with the FDA's Current Good Tissue Practice (CGTP) regulation for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). He also assists clients in obtaining FDA marketing approvals and clearances for diagnostic tests and medical devices. Leif is attuned to the needs of large corporations and start-up companies in formulating practical solutions to address FDA regulatory requirements.

He has deep insight into the FDA's QSR and CGTP regarding the design, development, and manufacturing of biologics and medical device requirements, including various radiological health devices, in vitro diagnostics (IVD) assays, and related laboratory instruments and accessories.

Previously, Leif held various operations and executive management positions in regulatory and quality for IVD, medical device, and biologic product companies and was responsible for development of regulatory strategies and premarketing submissions to the FDA and international authorities, as well as establishment and monitoring of good manufacturing practice programs compliant with FDA regulations.