Jason Brooke

M. Jason Brooke, MSE, JD, CSQE is an attorney and the Managing Member at Brooke Consulting, LLC—a boutique law and advisory firm that provides legal and consulting services to innovative medical device and digital health companies across the globe and at various stages of commercialization. Jason brings a focused expertise that combines nearly 20 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance. Jason 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. Jason has served as a Director and Global Lead of the Life Science Regulatory, Quality & Patient Safety practice within a multinational management consulting company, where he supported large and small U.S. and international medical device and digital health companies address the challenges that arise across the product lifecycle when commercializing medical devices, mobile/digital health technologies, and clinical decision support software.

In addition to advising on global market authorization strategies (for the U.S., E.U., U.K., Brazil, Saudi Arabia, India, and Australia, among others), Jason often supports the development of quality management systems, pre-clinical/clinical study designs, pre-submission strategies and preparation, regulatory submission development, post-market surveillance, regulatory investigations, supplier evaluation, and import/export activities. As a developer of medical device software and an ASQ-certified software quality engineer, he has a particular focus on legal, regulatory, and quality matters related to the development of Software as a Medical Device (SaMD), clinical decision support software, and AI/ML-based technologies. Jason is an Exemplar Global certified lead auditor and regularly audits and remediates quality systems for conformity to 21 C.F.R. Part 820, ISO 13485:2016, and other international standards (e.g., ISO 14971:2019 and IEC 62304:2006/A1:2015) in preparation for certification or in response to observations from the FDA or international Notified Bodies. He has extensive experience developing, assessing, and remediating post-market surveillance programs for identifying, evaluating, and reporting adverse events related to medical devices.