Compliance
Compliance guides for medical device software
Building regulated medical software means navigating a maze of regulations and standards. These guides break down the most important ones — what they require, who they apply to, and how to comply.
MDR — Medical Device Regulation
How the MDR differs from the MDD, the four risk classes, the 22 classification rules, and what it means for your SaMD.
Read the guide → International StandardIEC 62304 — Medical Device Software Lifecycle
The complete guide to IEC 62304 compliant software development — safety classes, SOUP, and all nine chapters of the standard.
Read the guide → EU RegulationGDPR — General Data Protection Regulation
What the GDPR means for medical apps — the seven principles, consent for health data, and the code of conduct for mobile health.
Read the guide → US LawHIPAA — Health Insurance Portability and Accountability Act
The Privacy and Security Rules, the seven technical safeguards for ePHI, and how HIPAA compares to GDPR.
Read the guide → International StandardISO 27001 — Information Security Management
The best-practice framework for managing information security risks, and how ISO 27701 extends it for privacy and GDPR.
Read the guide →Looking for our own certifications?
Extra Horizon is certified to ISO 13485, ISO 27001, ISO 27701, IEC 62304 and more — see the full list of platform regulations and certifications.
View our certifications →