Legal, Regulatory & Quality Compliance
The changing statutory and regulatory landscape demands a strategy to avoid the pitfalls.
Ensure your business handles compliance risk effectively
The medical device industry is one of the most heavily regulated, and when
paired with unparalleled innovation in the device and digital health spaces more
broadly, the risks for companies involved in the development, manufacture,
importation, and distribution are only rising. It is crucial that medical device and
digital health companies understand their legal and regulatory responsibilities.
How can Brooke & Associates help you navigate this
increasingly complex landscape?
We work with our clients as partners and trusted advisors to
translate legal and regulatory requirements into operational
excellence to achieve and maintain compliance.
Here are some of the ways we can help:
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. This includes building submission packages, planning and incorporating clinical studies, and interacting with regulators throughout the submission review process.
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, managing inspection/audit responses, and developing corrective action plans.
Regulatory Enforcement Support
Drafting responses, remediation plans, and periodic updates to regulators in cases of Form 483 inspection observations, notified body audit findings, Warning Letters, and injunction.
AI/ML Regulatory Requirements
Operationalizing regulatory frameworks for AI/ML-enabled medical devices into product submissions and the QMS.
Cybersecurity Regulatory Requirements
Incorporating cybersecurity requirements into product submissions and the QMS. In partnership with our sister company, Brooke Biomedical, we also provide SBOM creation, threat modeling, penetration testing, and static and dynamic code analysis from world class cybersecurity experts that bring both government and commercial experience to bear on your product ecosystem.
M&A Due Diligence
Leading regulatory evaluations for mergers & acquisitions, ensuring compliance risk assessments are integrated into transactional decisions.
Expert Witness & Litigation Support
Serving as an expert witness in FDA compliance-related litigation.
Marketing and Promotion
Evaluating promotional materials for legal and regulatory compliance.
U.S. Agent
Serving as U.S. agent to the FDA on behalf of foreign manufacturers.