8 regulatory standards built into every layer of the platform. Not bolted on. Not optional.
Health Insurance Portability and Accountability Act
Full HIPAA compliance with PHI encryption at rest and in transit, BAA execution, role-based access controls, and comprehensive audit trails.
Electronic Records; Electronic Signatures
Electronic records and signatures that meet FDA requirements for clinical trial data integrity, traceability, and non-repudiation.
Medical Devices Quality Management
Quality management system for medical device software development, ensuring consistent design, development, and delivery processes.
Medical Device Software Lifecycle
Software lifecycle processes for medical device software, from requirements through maintenance and decommissioning.
General Data Protection Regulation
EU data protection compliance with data subject rights, cross-border transfer safeguards, and privacy by design.
Good Clinical Practice
Aligned with the latest ICH GCP guidelines for quality-by-design clinical trials, risk-based monitoring, and proportionate approaches.
Unlike competitors who gate HIPAA BAA behind Enterprise pricing, we include it on Starter and above. Clinical software should be compliant by default.