Beanstock Ventures

A medical device regulatory consulting firm. BeanStock Ventures helps companies plan and navigate FDA requirements from early product development through post-market compliance. Services include regulatory strategy to identify a pathway to market, quality management system support, and technical documentation assistance for design history files. The team also provides audits, assessments, design reviews, and documentation creation or updates. FDA submission support covers Q-Submission, eStar review or assembly, and responses to FDA requests for additional information or deficiencies. As an FDA-recognized 510(k) Third Party Review Organization, the firm offers a 3P510(k) review pathway. After approval, it assists with company and product registrations and continuing FDA compliance. Its work focuses on medical devices and includes regulatory, technical, product development, and market considerations.