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.

Galen Data Compliance and Security

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 Certification Logo

HITRUST CSF r2 Certified

The most popular and widely adopted security framework in the U.S. healthcare industry

ISO 13485 Certification Logo

ISO 13485 Certified

We consistently meet customer and applicable regulatory requirements

HIPAA Certification Logo

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

Galen Data Compliance - Design Control
Galen Data Compliance - Privacy

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

Galen Data Compliance - Security

& 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

Designing for Compliance: QMS & Validation Testing for SaMD vs. Physical Devices
Choosing the Right API for Your Medical Device

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.

ELEVATE YOUR BUSINESS WITH

The Galen Cloud

The ultimate solution for cloud-connected medical devices – fast, safe, powerful and easy to use, all at an incredibly attractive price.

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