Shawnnah Monterrey founded BeanStock Ventures following a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for startups and mature organizations including Covidien and Illumina with an emphasis on the development of medical devices for life science, diagnostics, and clinical applications. Shawnnah often volunteers her time and expertise to the medical device community by serving as a mentor for various MedTech accelerators and startups, angel investor and as a recurring NIH SBIR grant reviewer.
Fast track your LDT to IVD FDA clearance
With the recent FDA issued proposed rule that would allow the FDA to regulate LTDs as medical devices, BeanStock Ventures has developed customized services and products that will enable LDT manufactures to rapidly comply with FDA regulations such as:Regulatory Strategy ServicesFDA Third-party reviewFDA compliance training technical templatesIVD analysis software platform
Digital Health Showcase:
BeanStock Consulting is an FDA-accredited third-party 510(k) review organization, which provides regulatory compliance products and services to minimize regulatory complexity, reduce development costs and increase time to market of innovative medical devices.