Carolyn MaCuan
Clinical Consultant
Carolyn is a regulatory and clinical consultant and leads CTM Medical Consulting. She has 20 years of combined experience in scientific, clinical, regulatory, and medical research and writing. Her areas of therapeutic experiences include medical devices, cardiology, virology, diabetes, orthopedics, ophthalmology, and vascular therapy.
Carolyn began her career as a research scientist in immunology, proteomics, and molecular diagnostics. She then transitioned to Regulatory Affairs while working at Medtronic in the Diabetes division. Later, at Edwards Lifesciences, she served as Manager of Scientific Communications in Clinical Affairs, responsible for global regulatory submissions for the Transcatheter Heart Valve business unit. She then became Director of Medical Writing at Network Partners, a management consulting firm, where she established the medical writing department. As CEO of CTM Medical Consulting, her consulting group supports small medical companies to Fortune 500 companies with navigating the requirements for US FDA, EU MDR, IVDR, and global regulatory compliance.
Carolyn holds a BSc degree in Biological Sciences from UC Irvine and a Master’s degree in Molecular Biology from USC.