Compliance and Security
made simple
With Galen Data, you can focus on medical innovation and offload compliance to us, ensuring you’re covered on all cyber-security and global regulations.
Speed Up Regulation
Built On a Foundation of Compliance and Security
Galen Data allows you to focus on medical innovation, ensuring you're covered on all cyber-security and global regulations.
HITRUST CSF r2 Certified
The most popular and widely adopted security framework in the U.S. healthcare industry
ISO 13485 Certified
We consistently meet customer and applicable regulatory requirements
HIPAA Compliant
We completely protect the privacy, security, and integrity of all health information
GDPR Compliant
All personal data is completely safe, private and secure throughout any process
Compliant & Secure
Every Certification You Need For Worldwide Success
One of our biggest value propositions is compliance to various regulatory and industry standards across design & development, security, and privacy arenas. We put compliance at the center of our product development and operations.
Design Control
From risk and design to manufacturing and implementation, we help you achieve crucial international certifications.
ISO 13485
IEC 62304
FDA
CE Mark
EU MDD/MDR, IVDD/IVDR
Health Canada
Australian TGA
Privacy
Protect your users' sensitive information, during all stages of its utilization, meeting international requirements.
HIPAA
EU/UK GDPR
PIPE DAct
Australian & New Zealand Privacy Act
Singapore, Philippines, Japan Data Privacy Act
US States - CA / MA / CO / VA Data Protection Laws
Security
Ensure the secure transmission and storage of data, with the highest standards of information security.
HITRUST
ISO/IEC 27001
UL-2900-1
& Much More
FDA CFR 820
ISO 14971
IEC 62304
COPPA (US)
Cloud Act (US)
& Many Others
Discover the Galen Cloud
Always up to date
Keep up with compliance
Offload your data regulations
Let Galen Data help you succeed
As regulatory and industry standards evolve around the world, we keep up with compliance changes to deliver peace of mind for our customers. We are your partners in this compliance journey.