ISO 13485 Certified
Our entire medical device software and hardware production lifecycle operates under a fully certified ISO 13485 Quality Management System, verified by accredited notified body audits for risk assessment and product traceability.
Enterprise Governance
Global Regulatory Clearances & Quality Management
Corsano Health develops, manufactures, and distributes medical-grade continuous wearable systems under strict European and international regulatory directives. Our certified ecosystem ensures global health systems, clinical research organizations (CROs), and pharmaceutical sponsors operate with total legal and clinical confidence.
EU CE-MDR Approval
The CardioWatch platform holds official CE mark certification under EU Medical Device Regulation (MDR 2017/745), ensuring compliance with stringent safety, clinical evaluation, and post-market surveillance benchmarks.
FDA 510(k) Clearance
Cleared by the United States Food and Drug Administration (FDA) for continuous patient monitoring, facilitating seamless clinical deployment across US hospital systems and international clinical research programs.
GDPR & Health Privacy
Designed under strict EU General Data Protection Regulation protocols, featuring pseudonymized data handling, tenant segregation, and sovereign data storage options tailored for multi-center hospital networks.
HIPAA Security Framework
Fully compliant with US Health Insurance Portability and Accountability Act guidelines, utilizing multi-layer encryption for Protected Health Information (PHI) across continuous data ingestion pipelines.
IEC 60601 & 62304 Standards
Engineered to satisfy IEC 60601-1 electrical safety and electromagnetic compatibility standards, alongside IEC 62304 medical device software lifecycle management requirements.
Enterprise Technical Dossier & Regulatory Documentation
Hospital procurement committees, institutional review boards (IRBs), and regulatory compliance teams can request our technical summaries, EU Declarations of Conformity, and ISO 13485 audit statements directly through our enterprise support team.
Cybersecurity Governance
Data Protection & Cloud Infrastructure Architecture
Continuous physiological monitoring requires uncompromising data protection. Corsano Health enforces zero-trust cloud architecture and hardware security mechanisms across all hospital and decentralized monitoring scenarios.
End-to-End Encryption
Physiological telemetry—including raw PPG, single-lead ECG strips, and derived vital signs—is encrypted at rest (AES-256) and in transit (TLS 1.3) from the CardioWatch wearable to cloud REST APIs.
Sovereign Cloud Hosting
Deployments are hosted within ISO/IEC 27001 certified data centers with regional hosting choices (EU, US, UK) to guarantee compliance with regional health data residency legislation.
Role-Based Access Control
Granular RBAC systems allow clinical department heads, trial coordinators, and platform administrators to define data accessibility scopes and secure multi-factor authentication policies.
Corporate Governance
Ethical Supply Chain & Environmental Sustainability
Corsano Health is committed to ethical business practices, transparent corporate conduct, and sustainable medical device manufacturing.
Responsible Manufacturing & Global Material Standards
We work exclusively with audited tier-1 suppliers following ethical labor practices. All continuous monitoring hardware complies with international environmental directives including RoHS (Restriction of Hazardous Substances) and REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals).
- Biocompatible Materials: Wristbands and sensor housing thoroughly tested for long-term clinical wear without dermal irritation.
- Conflict-Free Minerals: Sourcing policies strictly prohibit conflict-derived raw materials in electronic assemblies.
- Eco-Conscious Packaging: Recyclable packaging engineered for high-density international freight logistics.
Procurement Guidance
Compliance Questions from Healthcare Buyers
We supply complete regulatory packs including EU Declaration of Conformity (CE-MDR), Notified Body certification copies, FDA 510(k) clearance letters, ISO 13485 certification, and technical datasheets required by hospital legal and risk management departments.
Yes. The platform is designed for cross-border trial governance, featuring multi-region cloud infrastructure, standardized export formats for statistical analysis software, and compliance with GCP (Good Clinical Practice) data integrity guidelines.
Our integration protocols support HL7, FHIR, and RESTful APIs under strict OAuth2.0 authentication frameworks, permitting secure bi-directional telemetry stream transfer into electronic health record environments without compromising network security.
Request Regulatory Documentation or OEM Evaluation
Connect with our quality management and regulatory team to discuss institutional compliance requirements, pilot study approvals, or regional device availability.
Regulatory status and device feature availability are subject to local healthcare market authorizations, regional clearances, and applicable statutory guidelines.