Frequently Asked Questions

Extra Horizon is the compliant cloud component of your medical device. It consists of a number of building blocks called services that enable you to build all the cloud functionality you need: manage and authenticate users, store structured and unstructured data, implement custom business logic through functions, communicate with your users, and accept payments for subscriptions. All functionality is regulatory compliant and accessible through a REST API, a JavaScript SDK, a CLI, and a web management interface.

Extra Horizon offers you three different environments: Development, Staging, and Production. Typically you will use the first two to separate development from testing. Every cluster is a dedicated environment, with all Extra Horizon services included.

Extra Horizon provides a CLI (Command Line Interface) that you can easily integrate into your CI/CD coding pipelines. For example, to update your data schemas, you can keep a schema file in version control and run exh data schemas sync in your CI/CD pipeline to synchronise the schema with your cloud environment.

Extra Horizon is offered as a fully managed solution. It is built and managed in a regulated environment suited for medical devices, including complaint and incident management and CAPA processes that conform to ISO 13485 and are audited yearly. Extra Horizon acts as a critical supplier within your QMS as a legal manufacturer, taking away the responsibility of compliance maintenance.

An Extra Horizon cluster is a set of cloud services (Extra Horizon Services, load balancers, cybersecurity tools, etc.) that in combination with being hosted on a cloud environment make up the Extra Horizon product.

Your Extra Horizon cluster will be hosted by us as part of our service. We do not offer an Extra Horizon cluster as a non-managed or offline service.

In the Extra Horizon platform there is no multi-tenancy — this is a deliberate choice. Every cluster runs in a dedicated environment. For global deployments, additional production clusters can be set up per region. Sharing data between clusters is possible via the API.

Every customer gets their own cloud cluster and dedicated VPC to ensure complete separation of data and functionality between customers. The location of the servers can be decided by you, and single or multiple clusters can be used depending on your product, business, and regulatory requirements.

Extra Horizon provides a dynamic API. You can extend operations within the existing microservice network through configurations, and link your own developed services and clusters into your environment. This ensures complete scalability in functionality and complete flexibility.

In contrast with standard cloud providers, Extra Horizon provides a medically-compliant backend specifically for regulated MedTech products. We offer a fully-compliant, off-the-shelf backend that can be implemented quickly. Extra Horizon is also your partner in the e-health ecosystem, due to our proven track record in building digital health systems.

Customisation of the Extra Horizon platform entails the configuration of both the task and data schemas, configured in close tandem with frontend development. The partner-centric model of Extra Horizon allows us to work with selected software companies that have experience building on Extra Horizon.

Extra Horizon is built on a microservice infrastructure with automated load-balancing. We are continuously working on making multiple instances spin up automatically with increases in load.

Yes, we have multiple customers actively running their machine learning models within Extra Horizon. As machine learning is becoming a dedicated topic within medical device approval, we can advise on best practices and approaches to achieve compliance.

Extra Horizon is a cloud-based solution with a public URL endpoint. Every device connected over the internet (via cellular data, WiFi, or a regular internet connection) can communicate with the Extra Horizon services. All connections are secured with an SSL layer.

You can reach our support team via the live chat in the bottom right corner of the website, or by submitting a request through our contact form. Our team typically responds within one business day.

Yes — comprehensive developer documentation is available at docs.extrahorizon.com. It covers all platform services, the SDK, the CLI, and common integration patterns.

Extra Horizon holds certifications including ISO 13485:2016, ISO 27001:2022, ISO 27701:2019, IEC 62304:2015, and HDH/HDS. Our customers have also achieved CE Marking, FDA compliance, GDPR compliance, and HIPAA compliance using the platform.

Yes. Extra Horizon can act as a critical supplier within your Quality Management System as a legal manufacturer. We provide all the necessary documentation and audit support required for regulatory submissions.

Yes. Depending on your product and regulatory requirements, we can deploy dedicated clusters in specific geographic regions to meet local data residency regulations such as GDPR, HDS, or other country-specific requirements.

Every customer receives their own dedicated cloud cluster and VPC. There is no multi-tenancy in the Extra Horizon platform, ensuring complete data isolation between customers.

The location of your data storage can be decided by you. We work with public cloud infrastructure and can deploy your cluster in the region that meets your data governance and regulatory requirements.

Access to data is managed through the Extra Horizon User Service and Authentication Service. Role-based access control (RBAC) allows you to define fine-grained permissions for different user roles within your application.