Frequently Asked Questions

Extra Horizon is the compliant cloud component of your medical device. It consists of a number of building blocks that we call services that enable you to build all the cloud functionality that you need:

• Manage and authenticate users through the User Service and Authentication Service
• Store structured and unstructured data, and define access to that data through the Data Service and the File Service
• Implement custom business logic through functions in the Task Service
• Communicate with your users through the Mail Service
• Accept payments for subscriptions through the Payment Service

All this functionality is regulatory compliant and accessible through a REST API, a JavaScript Software Development Kit, a Command-Line Interface and a web management interface.

Extra Horizon offers you three different environments: Development, Staging, and Production. Typically, you will use the first two environments to separate development from testing, so that you can test out breaking things while the development team can continue their development efforts. In these environments, we have seen customers creating test scenarios that can be executed on a per release basis, or on another specified schedule.

Every cluster is a dedicated environment, with all Extra Horizon services included.

Extra Horizon provides you with an Extra Horizon CLI (Command Line Interface) that you can easily integrate into your CI/CD coding pipelines. For example, to update your data schema’s, you can keep a data schema file in your 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 to customers as a fully managed solution. Extra Horizon is not only the services that are offered to you, but it also includes the fact that it is built and managed in a regulated environment suited for medical devices. This environment also includes complaint and incident management and CAPA processes These processes conform to ISO 13485 and are audited on a yearly basis.

In case you build and maintain your own solution, or host a licensed product yourself, you will be responsible for maintaining and monitoring its compliance to regulatory standards.

Extra Horizon thus offers this to you as a managed solution, to take away this responsibility and act as a critical supplier within your QMS as a legal manufacturer.

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, or clusters, will be hosted by us as part of our service. This allows you to place it into your medical device without the hassle of taking the responsibility for it. We therefore do not offer an Extra Horizon cluster as a non-managed or offline service.

In the Extra Horizon platform, there is no multi-tenancy, and this is a deliberate choice.

Every single one of the clusters in the platform will run in a dedicated environment (even the development, staging and production clusters).

In order to generalise a public cloud infrastructure that is globally certified, there will be additional production clusters for different regions or countries. The frontend of your application, available in said region or country, will redirect the user to the right production cluster or environment. 

Sharing data between clusters is possible via the API. 

From a CI/CD perspective, this helps tremendously when it comes to controlled infrastructure maintenance with minimised risk. 

Every customer gets their own cloud cluster and dedicated VPC to ensure a complete separation of data and functionality between customers.

The location of the servers can be decided by you. A single or multiple clusters can be used to deploy your data storage and server requirements, depending on your product, business and regulatory requirements.

Extra Horizon provides you with a dynamic API. It offers you the ability to extend the operations within the existing microservice network through configurations. Additionally, you have the ability to extend the functionalities by linking 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 in no time. Additionally, Extra Horizon is 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. This is obviously 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 currently 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 advice some best practices in what approaches are best suited in order for you to achieve compliance.

Extra Horizon is a cloud-based solution. A public url endpoint will become available. Every device connected over the internet (via a cellular data, wifi or regular internet connection) will be able to communicate to the Extra Horizon services. All connections are secured with an SSL layer.