Medical devices manufacturer 24sens GmbH successfully ISO certified

Cardiology expert convinces with safety

Austrian startup 24sens GmbH is now an ISO-certified developer, manufacturer and distributor of active medical devices.
The product, a smart-textile chest strap for monitoring and recording heart rates, particularly supports patients with atrial fibrillation to improve their quality of life.

"Medical devices are used on people. Therefore, they have to meet high expectations in terms of reliability and safety," says Günther Grabher, who founded the company 24sens together with IT entrepreneur and AI expert Rajat Khare. With ISO-certification, 24sens has laid the basis to operate as developer, manufacturer and distributor of medical devices for cardiology.

4.5 million Euros for research and innovation

Product certification in accordance with the new Medical Device Regulation (MDR) is planned for the beginning of 2022. This new regulation has been adapted by the European Commission to technological and scientific progress in order to ensure safety and transparency for patients and the public. "The new directives are a great challenge for medical-technical companies - especially for start-ups like us. As an ISO-certified company for medical technology products, we now have the prerequisites for entering the international market," Günther Grabher says. Around 4.5 million Euros are to be invested in the company by 2025, including research and innovation. New jobs are also to be created. Once the approval process has been completed, the start-up will go into series production.

ISO-certification successfully completed

“24sens GmbH was audited by the renowned certification body DQS-Med in Frankfurt which now successfully certifies full quality management according to DIN EN ISO 13485, an international standard that defines the quality management requirements for medical device manufacturers," says Markus Sonderegger, CTO of 24sens. Austrian startup 24sens GmbH is now an IOS-certified developer, manufacturer and distributor of active medical devices. The product, a smart-textile shoulder strap for monitoring and recording heart rates, supports in particular patient:in with atrial fibrillation improves their quality of life.

"Medical devices are used on people. Therefore, it goes without saying that they have to meet high expectations in terms of reliability and safety," says Günther Grabher, who founded the company 24sens together with IT entrepreneur and AI expert Rajat Khare. With ISO certification, 24sens has laid the foundation to operate as a developer, manufacturer and distributor of medical devices for cardiology.

4.5 million euros for research and innovation

Product certification in accordance with the new Medical Device Regulation (MDR) is planned for the beginning of 2022. This new regulation has been adapted by the European Commission to technological and scientific progress in order to ensure safety and transparency for patients and the public in the future. "The new directives are a great challenge for medical-technical companies - especially for start-ups like us. As an ISO-certified company for medical technology products, we now have the prerequisites for entering the international market," Günther Grabher is pleased to say. Around 4.5 million euros are to be invested in the company by 2025, including research and innovation, and new jobs are also to be created. Once the approval process has been completed, the start-up will go into series production with its new development.

ISO certification successfully completed

24sens GmbH was audited by the renowned certification body DQS-Med in Frankfurt and now successfully certifies full quality management according to DIN EN ISO 13485, an international standard that defines the quality management requirements for medical device manufacturers," says Markus Sonderegger, CEO of 24sens. The audit’s focus was on four areas: the responsibility of the company's management, which defines the quality policy and objectives, the management of infrastructure and human resources, product realization and service provision, and the analysis and improvement process.