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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 for a trusted supplier ...

ISO 13485:2016

Quality Management System for Medical Devices

IEC 62304:2015

Software Development Life Cycle for Medical Devices

EU Cloud Coc

European Union Cloud Code of Conduct

ISO 27001:2017

Information Security Management System

ISO 27701:2019

Privacy Information Management System

... to obtain these yourself ↓

CE Marking

Quality Management System for Medical Devices

IEC 62304:2015

Software Development Life Cycle for Medical Devices

EU Cloud Coc

European Union Cloud Code of Conduct

HIPAA Compliance

Quality Management System for Medical Devices

TGA Compliance

Software Development Life Cycle for Medical Devices

And many more

Choose a trusted supplier for your patient data privacy, and cybersecurity

ISO 13485:2016

Quality Management System for Medical Devices

ISO 27001:2017

Information Security Management System

ISO 27701:2019

Privacy Information Management System

IEC 62304:2015

Software Development Life Cycle for Medical Devices

EU Cloud CoC

European Union Cloud Code of Conduct

IEC 62304:2015

Software Development Life Cycle for Medical Devices

EU Cloud CoC

European Union Cloud Code of Conduct

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 Health Insurance Portability Act [US]

Worldwide

Extra Horizon customers have achieved compliance in South-East Asia, Oceania and the Middle East

And many more

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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Extra Horizon Regulatory Privacy Cybersecurity

COMPLIANCY RELATED RESOURCES

Get up to speed quickly with our free ebooks

Building and releasing medical device software is hard, very hard. Here at Extra Horizon we have had

IEC 62304 - A thorough yet simple guide

By Free ebook • 11 Oct, 2022

Get a thorough yet simple guide to IEC 62304 in Extra Horizon's ebook. Unlock insights into software development for medical devices.

ISO 13485 Ebook Medical Device Development

ISO 13485:2016: Thirteen Boxes to Tick on the Path to Certification

By Free ebook • 27 Apr, 2022

Learn the thirteen essential boxes to tick on the path to ISO 13485:2016 certification. Gain insights and guidance in Extra Horizon's ebook. Download now!

The 6 Essentials To Building A Digital Health Application

The 6 Essentials To Building A Successful Digital Health Application

By Free ebook • 16 Mar, 2022

Discover the 6 essentials for building and deploying successful digital health products. Learn from FibriCheck's example on the Extra Horizon platform.