M. Jason Brooke Esq.*

M. Jason Brooke, MSE, JD, CSQE is the Managing Member at Brooke & Associates—a digital health legal and regulatory advisory firm. Jason 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. 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.

* Admitted to practice law in Maryland and the District of Columbia

Kyoung-A Cho, MSE, RAC

Kyoung-A Cho, MSE, RAC brings nearly a decade of experience in the medical device industry. With a background in biomedical and electrical engineering, Kyoung-A began as a product development engineer, with a focus on software development. After leading efforts for a 510(k) clearance, she found a passion for regulatory and quality affairs. Kyoung-A now brings her technical background to help companies develop and maintain safe and effective medical devices with a focus on quality assurance and regulatory compliance.

Rebecca Vaudreuil, MEng

Rebecca Vaudreuil, MEng is a consultant specializing in quality systems and regulatory compliance for medical devices. An ISO 13485 Lead Auditor, Rebecca excels in tailoring quality systems to meet regulatory standards while driving efficiency and sustainability. Rebecca develops regulatory strategies for a wide range of devices, including hardware and electronics, software including AI/ML, and low-risk health products. She prepares premarket submissions to global regulators, leveraging her engineering background to integrate key medical device disciplines such as cybersecurity and interoperability, clinical research, biocompatibility, electronics, and software development. She evaluates current events and emerging regulations for impacts on her clients and the field.