BioMedSA New Members: January 2024

BioMedSA’s Board of Directors approved 4 new memberships in January 2024: Bobi, Inc., Eby Investments and Insurance, Mentor Documents and Consulting, and SalutarisMD.

Bobi, Inc. is an AI company that seeks to use advancements in AI and IT to provide intelligent monitoring and alerting solutions during pregnancy. Through a team of medical, scientific, data, and IT professionals, Bobi Health’s goal is to impact maternal and infant mortality rates and improve individual health outcomes.

Eby Investments and Insurance serves the life science and healthcare industry by providing an individualized approach to address the risk management needs of companies and individuals including life insurance, long-term care insurance, individual disability insurance, income annuities and long term investment strategy support.

Mentor Documents and Consulting provides customized solutions for alignment with Quality System Regulation (QSR) per 21 CFR Part 820, FDA requirements and ISO 13485; and, consulting services for quality management, regulatory compliance, 510(K) Submissions, GUDID UDI Labeling Compliance, Validation Engineering, Project Management, Technical Writing, CAPA Management, and current Good Manufacturing Practice (cGMP).  These services are offered to support manufacturing processes, prepare for inspections, and project management.

SalutarisMD is seeks to provide a cost-effective, accessible treatment for back of the eye disease for the 20+ million people over 50 years old who suffer vision loss from advanced, age-related, macular degeneration (wet-AMD) using The BetaCurve – a clinical stage device that has portions registered as a Class I Medical Device, Class II device, and FDA 510(k) clearance.  The device is currently under study to reduce the treatment burden to patients with macular degeneration.