Speaker Profile
CEO, BeanStock Ventures
Biography
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.
Talk
Fast Track Your LDT to IVD FDA Clearance
With the recent FDA issued proposed rule that would allow the FDA to regulate LDTs 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 Services, FDA Third-party review, FDA compliance training, technical templates, IVD analysis software platform
Digital Health Showcase:
BeanStock Ventures
BeanStock Consulting is an FDA-accredited third-party 510(k) review organization, which provides Regulatory Strategy Services, FDA Third-party review, FDA compliance training, technical templates, and IVD analysis software platform.
Session Abstract – PMWC 2024 Silicon Valley
The PMWC 2024 Digital Health Showcase will provide 15 minute speaking opportunities for selected companies working with the latest technologies in precision medicine to highlight their contributions to the field.
