What problem does it solve? Medical device and digital health teams must coordinate regulatory affairs, clinical, quality, and legal work across standards like FDA 510(k), EU MDR, ISO 13485, and HIPAA, which is difficult to orchestrate with a single general-purpose agent. ## Core Features & Use Cases - Pre-configured department agents: Activates RA, R&D, Quality, Legal, and Operations departments mapped to FDA 510(k), CE Marking, ISO 13485, IEC 62304, HIPAA, and ISO 14971 coverage. - Orchestration prompt templates: Provides ready-made objectives such as preparing a 510(k) substantial equivalence summary or triaging adverse event reports against MDR Article 87. - Compliance guardrails: Enforces PHI anonymization, 21 CFR Part 11 audit trails, and secure production mode settings. - Use Case: A regulatory affairs lead asks the agent to draft a 510(k) summary for a continuous glucose monitor with a predicate comparison table, coordinating RA, R&D, and Quality departments in one workflow. ## Quick Start Ask the agent to prepare a 510(k) substantial equivalence summary for your device using the RA, R&D, and Quality departments with a named predicate device.
