AI Agency in Irvine, CA

Specialty pharma marketing teams, clinical-stage biotechs, and CROs along IBC and the Spectrum run AI programs that move through MLR review cycles. Customer-facing AI — patient-information chatbots, HCP portals, branded content generators — gets architected so every output category maps to current 510(k) clearance language for devices or FDA 21 CFR Part 202 promotional rules for drugs. Off-label promotion guards sit in the prompt layer. RAG systems index only approved labeling and published clinical data. Internal AI for clinical-trial document review runs inside the company's controlled environment with HIPAA-aware access. The engagement documents every system in a format the MLR team can review without reading code, and quarterly reviews track regulatory shifts.

Cardiovascular, ophthalmic, and surgical-instrument companies anchored around Edwards Lifesciences and Masimo run AI programs constrained by FDA 21 CFR Part 820 quality-system requirements, claims-substantiation tied to 510(k) and PMA filings, and ISO 13485 alignment. Customer-facing AI generators for product pages, sales collateral, and HCP communications get prompt patterns that refuse claims outside cleared indications. Internal AI for complaint handling, MDR reporting, and post-market surveillance runs with audit logging that satisfies FDA inspection. The agency engagement partners with the company's regulatory affairs team rather than working around it, and the program documents the AI surfaces against the QMS in a format that matches the company's existing design-control practices.

RIAs, wealth managers, mortgage lenders, and B2B fintechs along Jamboree and across the Newport line run AI programs that have to clear the SEC Marketing Rule (206(4)-1), FINRA Rule 2210, and California DFPI disclosure standards. Customer-facing AI — RIA websites, advisor chatbots, lender qualification flows — gets architected so testimonials, performance claims, and forward-looking statements either exclude regulated content or carry mandated disclosure. RAG systems index only approved marketing material, current Form ADV disclosures, and published carrier-rate data. Internal AI for portfolio analysis or underwriting runs with audit trails that survive SEC examination. The agency program reviews every public-facing surface against the rule before launch and documents the posture for compliance officers.