Brynn advises FDA-regulated clients on quality, regulatory, and compliance matters. She counsels clients – from small startups to global international companies – on a wide range of issues, from clinical trials to product development and regulatory submissions, quality management system (QMS) audits and implementation, and supplier and supply chain management and control.
With Brynn’s wide-ranging in-house experience as an engineer along with her private practice experience as an attorney, she understands both the technical and legal challenges that her clients face. That knowledge and experience allows her to provide solutions that are not only compliant with the law, but also practical and actionable.
- 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.
- Juris Doctor, Mitchell Hamline School of Law
- Bachelor of Biomedical Engineering, University of Minnesota (Twin Cities)
Bar Admissions and Qualifications
- ISO 13485:2003 Lead Auditor (TPECS)
- Member, Minnesota State Bar Association - Food, Drug and Device Law Section
- Member, Minnesota State Bar Association - Heath Law Section
- Adjunct Professor of Law, Mitchell Hamline School of Law - Drug and Device Law