Compliance

All OpenRad entities—OpenRad Services UK Ltd., OpenRad Germany GmbH, OpenRad Services S.A.R.L. (details see contact page)—are the agreed distributors of the following products manufactured and registered by the companies Biotronics3D Ltd. and Visbion Ltd.:

• Biotronics3D’s product 3Dnet is now marketed and sold under the name of OpenRad Cloud.
• Visbion’s product Medical PACS (xPACS) is now marketed and sold under the name OpenRad Cube.

Please note for the US: OpenRad Cloud is not FDA-cleared yet, but in the process of acquiring a clearance.

For compliance information of both manufacturers, please check the below certificates.

Compliance Information of Biotronics3D Ltd.

• Declaration of Conformity
• Medical Devices Regulation Certificate
• ISO 13485 Certificate
• ISO 27001 Certificate
• Cyber Essentials Plus Certificate
• NHS Data Security & Protection Certificate