EXTRA HORIZON LICENSE MODEL

A license model tailored to your needs

Building a digital medical device takes you through several stages. We have a license tailored for each of those stages.

Development cluster

Developer tools (CLI, SDK, ...)

Developer documentation

Direct communication with our engineers

Turn your idea into a prototype while performing all the necessary research. You will develop a comprehensive, working prototype with the help of the Extra Horizon development cluster. 

Included in the license

Research License

*Research team qualifications:

  • Team size: max 4 FTE
  • Funding: max €1 MM
  • Connected to university and/or hospital

Development cluster

Developer tools (CLI, SDK, ...)

Developer documentation

Direct communication with our engineers

Build your first true digital medical product to pass the clinical validation stage. We provide you with all the infrastructure needed to comply with the medical security and privacy standards.

Included in the license

Pre-market License

Up to 2 Extra clusters (Staging & Production)

Mutual Data Protection Agreement (DPA)

ISO27001 & ISO27701 certificate access

Basic Service Level Agreement (SLA)

Development cluster

Commercial License

Take the next steps to bring your medical device to the market and beyond by getting your CE, FDA, ... mark. Extra Horizon is ISO13485 certified, enabling you to meet the regulatory obligations with ease.

Developer tools (CLI, SDK, ...)

Developer documentation

Direct communication with our engineers

Included in the license

2 Extra clusters (Staging & Production)

Mutual Data Protection Agreement (DPA)

ISO27001 & ISO27701 certificate access

Production Service Level Agreement (SLA)

Auditable cluster history records

ISO13485:2016 QMS certificate access

Design History File (DHF) template

Critical Supplier Questionnaire support

IEC62304 doc. for custom development

CAPA follow-up for supplier complaints

Additional clusters are possible for new regions

Ready to give our platform a go?

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