Brynn Stanley
Associate Attorney
O: 651.364.7488
M: 763.458.1295
Brynn Stanley advises medical device and life sciences companies on FDA regulatory compliance, quality systems, and clinical research matters. With a background in biomedical engineering, she brings a technically informed approach to regulatory documentation, quality management systems, and compliance strategy. Clients rely on Brynn for practical support across product development, submissions, and clinical operations.
Brynn’s technical background enables her to work effectively with engineering, quality, and clinical teams on design controls, risk management documentation, and quality system implementation. She assists clients in preparing and maintaining documentation aligned with FDA requirements and international quality standards.
Her practice also includes advising on clinical investigation compliance, Institutional Review Board considerations, and regulatory documentation supporting product development milestones
Representative Experience
- Counsels clients on supply chain planning and management, including supplier assessments, audits, and quality agreements.
- Performs Quality Management System (QMS) assessments and audits and assists clients on QMS design and implementation.
- Advises clients on new product development and design change management, including Program Management, development of the Risk Management File, the Design History File, and FDA regulatory submissions.
- Assists clients with product recalls, corrections and removals, corrective and preventive actions (CAPA), and health hazard evaluations.
- Advises clients on US and global clinical trials, including drafting and negotiating clinical trial agreements, informed consent forms and patient authorizations.
- Reviews product labeling and product claims including food packaging, instructions for use and patient guides, dietary supplements, and cosmetics.
Education
- Juris Doctor, Mitchell Hamline School of Law
- Bachelor of Biomedical Engineering, University of Minnesota (Twin Cities)
Bar Admissions and Qualifications
- Minnesota
- ISO 13485:2003 Lead Auditor (TPECS)
Memberships
- Member, Minnesota State Bar Association - Food, Drug and Device Law Section
- Member, Minnesota State Bar Association - Heath Law Section
Faculty Appointments
- Adjunct Professor of Law, Mitchell Hamline School of Law - Drug and Device Law