We Are Brooke & Associates, Legal and Regulatory Advisors
Headquartered in the Washington, DC metropolitan area, Brooke & Associates specializes in matters critical to the medical device, digital health, and digital therapeutics industries, with a particular focus on hardware and software medical devices incorporating wearable sensors, artificial intelligence/machine learning, and virtual, augmented, and mixed reality technologies.
About Brooke & Associates
Brooke & Associates advises clients of all stages, sizes, and clinical, therapeutic, and technological domains to address issues across a broad spectrum—from counseling on compliance with legal and regulatory requirements, providing practical guidance on product-specific market authorization strategies, and serving as an advocate for development of smart policy.
Our extensive, industry-specific experience combined with our strong client focus uniquely positions us to provide guidance through pre- and post-market challenges.
Our Practice Areas
We offer our clients an array of services critical to the successful research, development, and commercialization of innovative medical devices.
Regulatory Strategy and Submission Support
Developing and managing premarket regulatory strategies (e.g., IDE, Q-Sub, 513(g), 510(k), De Novo request, PMA, CE, UKCA) for commercialization in the U.S., EU, and other international markets.
Regulatory Compliance
Advising executive, quality and regulatory teams on global regulatory requirements and assisting in the establishment and/or remediation of Quality Management Systems (QMSs).
Contracts
Drafting and negotiating device-specific contracts (e.g., purchase order agreements, supplier quality agreements, research agreements).
Building & Enhancing Quality and Regulatory Organizations
Advising executive teams on optimal organizational structures and staffing levels for quality, regulatory, and supporting functions.
Audit & Inspection Leadership
Preparing organizations for regulatory inspections/audits, providing real-time management of active inspections/audits.
Regulatory Enforcement Support
Drafting responses, remediation plans, and periodic updates to regulators.
In conjunction with our sister company—Brooke Biomedical—we support clients with cybersecurity compliance requirements, including threat modeling, SBOM maintenance, and penetration testing.
Core Team
Brooke & Associates is dedicated to providing client-focused, high-quality service. We leverage decades of industry-specific expertise to deliver efficient and effective guidance and support.
M. Jason Brooke, Esq.*
MANAGING MEMBER & ATTORNEY
Eric Henry
SR. ADVISOR, HEAD OF QUALITY COMPLIANCE
Kyoung-A Cho, MSE, RAC
PRINCIPAL CONSULTANT
Rebecca Vaudreuil, MEng
SENIOR CONSULTANT
Additional Advisors
Paula Burge
Senior Advisor
Robert Jarrin
Special Advisor
Andrea Miller
Principal Consultant
Get in Touch
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Brooke & Associates is a boutique law and advisory firm that provides legal and consulting services to innovative medical device, digital health, and digital therapeutics companies across the globe and at various stages of commercialization.
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