NEU!! Entwickelt SxMDs mit einem strukturierten eQMS, einschließlich auditfähriger SxMD-Vorlagen, die an EU- und US-Standards angepasst sind. Mehr Erfahren!
Cloud Connectivity, Compliance, and Security simplified.
Focus on pushing the boundaries of medical innovation while we take care of your compliance and security needs by connecting your medical device to the cloud.
Navigate regulations with clarity.
Stay fully compliant with the latest global regulations, including cybersecurity frameworks, data privacy laws, and industry-specific standards.
HITRUST CSF r2 Certified
Galen Cloud meets the HITRUST CSF r2 standards, which are the most widely recognized framework for healthcare cybersecurity.
This certification ensures that your data is secured with industry leading practices and demonstrates our strong commitment to safeguarding your data.
Our HITRUST certification covers controls from ISO 27001, SOC 2, HIPAA and other industry standards on security and privacy.
ISO 13485 Certified
This certification demonstrates our commitment to maintaining a high-quality management system in development and operations of the Galen Cloud.
Galen Cloud is developed under IEC 62304, and ISO 14971 compliant processes..
HIPAA Compliant
Galen Cloud adheres to HIPAA regulations, ensuring that all health information is handled with the utmost privacy and security.
Compliance with HIPAA means that personal health data is protected across all stages of handling.
GDPR Compliant
Galen Cloud also complies with the General Data Protection Regulation (GDPR), focusing on the protection and privacy of personal data within the European Union and United Kingdom.
GDPR compliance ensures that individuals' data is handled with transparency, fairness, and accountability.
It covers all processing of personal data, whether stored, transmitted, or used.
Our customers have successfully received clearance/approval from US FDA, CE Mark, EU MDD/MDR, IVDD/IVDR, Health Canada, Australian TGA, and others.
Every Certification You Need For Worldwide Success
Hear from our customers
"On top of Galen having the best solution in the industry, for me, it's the people. They have built trust with our team, I trust them, and that is invaluable for us.”
Emily Granger, Senior Marketing Officer, Delphi
Meldet euch für unseren Newsletter an.