Cytodyme

Cytodyme is a San Diego-based software company serving quality and regulatory affairs teams at medical device and life science organizations. Its platform centralizes complaints, investigations and vigilance activities, applies consistent severity, risk and reportability criteria, and tracks trends across products, time periods and regions to surface emerging signals. Intake features automatically group similar complaints even when they are described differently, risk and patient-impact assessments update as new facts emerge, and reportability decisions are documented with their rationale. The system links unique device identifier (UDI), lot, serial and product history data that would otherwise sit in separate systems.

The product turns ongoing post-market work into audit-ready reports by connecting post-market surveillance data, supporting evidence and decisions as they change, and by capturing literature review and performance evidence with preserved citations and rationale. It supports PSUR, PMPF, CER and other MDR/IVDR post-market reporting workflows, and drafts MDR, IVDR and FDA reports from live data. Literature screening runs continuously in the background. A regulatory-change module monitors updates to regulations, guidance and standards across regions, identifies which products, documents and reports are affected, and maintains a traceable record of what changed, what was reviewed and what was updated. Every change, decision and approval is recorded automatically in end-to-end audit trails, and the platform is designed to support EMA and FDA 21 CFR Part 11 requirements.

Public descriptions of the company also frame it more broadly as automating clinical document generation and management for biotech and life science companies, using generative AI to reduce the time, cost and headcount associated with clinical development workflows such as preparing and storing FDA submission documents.

Founding story

Cytodyme was co-founded by Dennis "D.J." White (CEO), Tammy Ogden (COO, also described as Chief Business Officer) and Stephen Brown-Bourne (CTO). White has more than ten years of experience in the biopharmaceutical sector across cell and gene therapy, including strategic roles at Kite Pharma and ImmunityBio, and was pursuing an MBA at the University of California, San Diego with an emphasis on entrepreneurship, new product development and financing. Ogden is a serial entrepreneur with a background in B2B SaaS customer acquisition and revenue operations and was an MBA candidate at UC San Diego, where she served as President of the Women of Rady Club and Vice President of the Venture Capital Club.

Business model

Cytodyme sells a software platform to regulated life science organizations, with prospective customers directed to book a demo rather than self-serve sign-up, indicating a direct enterprise sales motion.

Traction

Testimonials on the company site are attributed to quality and regulatory leaders at medical device, surgical device, orthopedic and diagnostic manufacturers, who cite documentation workloads of ten to fifteen hours per week and reports that take days to a week to produce. The company is listed with 1-10 employees at pre-seed stage.

Latest developments

Cytodyme joined the Fall 2025 Techstars San Diego Powered by SDSU accelerator class announced on 8 September 2025, and was included among Techstars San Diego portfolio companies in the Techstars December 2025 update published in January 2026.