Medical Device
ISO 13485:2016
Medical devices — Quality management systems
Trust Center · Security & Compliance
Building Trust
Secure data, traceable AI, and compliance built in from day one — aligned with the frameworks that matter in life sciences.
Medical Device
ISO 14971:2019
Application of risk management to medical devices
Medical Device
IEC 62304:2006/AMD1:2015
Medical device software — Software life cycle processes
Medical Device
IEC 62366-1:2015
IEC 62366 is the international standard for applying usability engineering (Human Factors Engineering) to medical devices.
Regulatory
FDA 21 CFR Part 11
Electronic records and electronic signatures
AI Governance
ISO 42001:2023
Artificial intelligence — Management system
AI Governance
EU AI Act
Regulation (EU) 2024/1689
European Union artificial intelligence regulation
Data & Privacy
ISO 27001:2022
Information security management systems
Data & Privacy
HIPAA Security Rule
2024 amendments
US healthcare data security and safeguards
Data & Privacy
GDPR
(EU) 2016/679
EU general data protection regulation
Data & Privacy
DPDPA 2023
India digital personal data protection act
How we protect your data
Data Privacy
Your data is yours. We do not train our foundational models on your proprietary data without explicit consent. Data is processed in line with your agreements and applicable law.
Traceable AI
Full traceability for every AI-generated insight. Audit-ready validation and source-linked outputs so you can verify and defend every decision.
Infrastructure
Hosted on secure, compliant cloud infrastructure with end-to-end encryption at rest and in transit. Rigorous access controls and monitoring.
Access Control
Enterprise-ready role-based access control (RBAC) and SSO integration so only authorized personnel access sensitive data.