Legal, Regulatory & Quality Compliance

Ensure your business is in compliance

The medical device industry is one of the most heavily regulated and companies involved in the development, manufacture, importation, and distribution must understand their legal and regulatory compliance obligations.

How can Brooke & Associates help your business?

We work in partnership with our clients to translate legal and regulatory requirements into operational activities that achieve and maintain compliance.

Example services include:
• Drafting and negotiating device-specific contracts (e.g., purchase order agreements, supplier quality agreements, research agreements)
• Developing and managing premarket regulatory strategies for commercialization in the US, EU, and other international markets
• Drafting and advising on premarket submissions (e.g., IDEs, Q-Subs, 513(g)s, 510(k)s, De Novo Requests, PMAs, CE submissions, UKCA submissions) across the risk spectrum (from SaMD to active implantables)
• Drafting responses and remediation plans for regulatory findings (e.g., FDA Form 483 and Warning Letters)
• Evaluating promotional materials for legal and regulatory compliance
• Serving as US agent to the FDA on behalf of foreign manufacturers