Regulatory fast-track
A backend platform built with medical compliance in mind
Choose a compliant solution for building digital medical applications, easing the regulatory challenge in the form of a qualified backend supplier.
Choose a trusted supplier for your patient data privacy, and cybersecurity
ISO 13485:2016
Quality Management System for Medical Devices
ISO 27001:2022
Information Security Management System
ISO 27701:2019
Privacy Information Management System
IEC 62304:2015
Software Development Life Cycle for Medical Devices
HDH / HDS
Compliant Health Data Hosting
To obtain these yourself ↓
CE Marking
Extra Horizon customers have achieved CE approvals.
FDA Compliance
Extra Horizon customers have achieved FDA approvals.
GDPR
Extra Horizon is compliant with all GDPR regulations.
HIPAA Compliance
Protecting health information through the Health Insurance Portability Act (US).
Worldwide
Extra Horizon customers have achieved compliance in South-East Asia, Oceania and the Middle East.
And many more
Contact us for other specific regulations!
The centre of software quality
Put compliance at the centre of your digital medical solution
In highly regulated environments like digital health, the things that hold the most risks are losing time and not getting your product compliant in order to launch your solution. Above that, once you get your product compliant, you'll have to keep investing time in staying compliant.
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eBooks
Deepen your knowledge
IEC 62304: A Thorough Yet Simple Guide
Everything you need to know about the IEC 62304 standard for medical device software development — explained in plain language.
ISO 13485:2016 — Thirteen Boxes to Tick on the Path to Certification
A practical checklist-driven guide to achieving ISO 13485 certification for your Quality Management System.
The Six Essentials to Building a Successful Digital Health Application
From architecture choices to regulatory positioning — the six things every digital health team needs to get right before launch.