CUREosity GmbH has been officially ISO certified following a thorough audit. As of August 22, 2023, Berlin Cert GmbH has confirmed that CUREosity has implemented and is applying a quality management system in accordance with the ISO 13485 standard.
Caesar van Heyningen (Chief Executive Officer) commented: “Following the CE certification of the CUREO software, ISO certification marks another important milestone for CUREosity. As a therapy system, CUREO convinces users and patients alike with its safety, quality, and its efficient and effective therapeutic outcomes.”

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ISO 13485 is an internationally recognized standard outlining the requirements for quality management systems for developers, manufacturers, and suppliers of medical devices. At CUREosity, these requirements apply to the development, delivery, and distribution of stand-alone software for motor, cognitive, and sensory virtual reality therapy. The goal is to ensure the quality and safety of products and processes.
CUREosity successfully completed the accreditation process and has been certified under DIN EN ISO 13485:2021 since August 22, 2023. The certification was carried out by Berlin Cert, a designated testing and certification body for medical devices.

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In 2021, CUREO initially received CE marking under the EU Medical Device Directive (MDD), and in 2022, it was re-certified as a medical device in accordance with the European Medical Device Regulation (MDR). These approvals, in addition to the new ISO certification, underscore CUREosity’s unwavering commitment to product safety and quality, as well as the consistent adherence to the highest standards in both product development and processes.

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Dr. Petra Söhnlein, who is responsible for quality management at CUREosity GmbH, expressed her satisfaction with Berlin Cert’s decision:

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“Our top priority is to develop safe products for our customers that are consistently based on the latest technology. The ISO standard provides us with clear guidelines that we follow in order to sustainably ensure this quality and safety.”
Caesar van Heyningen also emphasized further benefits of the certification:

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“The ISO certificate is highly regarded and recognized internationally, even outside the EU. We are therefore pleased that our products are now also available to many customers in international markets.”

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