A strong commitment to quality: stappone maintains ISO 13485 certification
For companies in the professional medical technology sector, the ISO 13485 certification is of crucial importance. It represents the international standard for proof of an effective quality management system. Already since 2020, stappone has been certified according to this standard and has successfully maintained the strict standards this year as well.
The ISO 13485 certification not only regulates product quality, but also ensures that the company meets certain standards. After last year’s renewal, stappone now successfully passed the recertification audit.
Two specially trained auditors from Quality Austria spent a whole day at stappone’s headquarters in Vienna and examined the quality management system in detail. Workflows and company management were closely scrutinized to ensure that the strict rules, procedures, and processes are firmly integrated into everyday work – a fundamental value that is of central importance to stappone.
Better quality for better health
The stappone solutions are medically certified devices, which means highest quality and product safety. The intelligent stappone sensor soles are inserted into comfortable shoes and measure the patients’ foot pressure load.
Our products STAPPONE Medical and STAPPONE Physio consist of the intelligent stappone sensor soles and the corresponding software. This enables visual live-biofeedback on a tablet or PC as well as objective data on other movement-relevant parameters. With this, gait analysis becomes simple, quick, and objective.
STAPPONE Rehab, another stappone product, consists of the stappone sensor soles and the corresponding app that helps patients precisely maintain a prescribed load limit. The app provides visual, acoustic and/or haptic feedback to ensure correct and safe training at home while speeding up the healing process.
The renewed ISO 13485 certification is of important significance for stappone and officially confirms the company’s high-quality standards. Consistent adherence to and implementation of these demanding standards enables stappone to offer safe high-quality medical devices that contribute to a better and faster recovery.
Do you have questions about the use of the stappone products? Contact us! We are always at your disposal.
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