![]() We strive for excellence, every detail and every opinion always matters. “The ISO13485 certification is an important step to achieve high levels of efficiency and quality of our products, providing high customer and patient satisfaction. With the implementation of a QMS according to ISO 13485, we commit to continuous improvement and we demonstrate that we are able to produce safe, high quality and top performance medical devices that aim to improve the efficiency of rehabilitation and promote patient’s reintegration into the community. ![]() ISO 13485:2016 specifies the requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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