Jason Brooke

Jason Brooke

Managing Member and Attorney
Brooke and Associates

M. Jason Brooke, MSE, JD, CSQE is the Managing Member at Brooke & Associates — a digital health legal and regulatory advisory firm. Mr. Brooke offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant. He brings a focused expertise in the medical device industry that combines 20 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance. Mr. Brooke has conducted scientific research (pre-clinical and clinical) and technology development in academic and industry environments as a biomedical engineer, worked within the FDA’s Center for Devices and Radiological Health as a regulatory affairs program analyst, counseled clients as an attorney and consultant focused on the medical device and digital health space, and served as the chief executive officer, general counsel, and vice-president of regulatory and quality for small medical device companies.



Device – Defending Machine Learning in Inspections