Quality Management System at Aether Biomedical Poland is officially ISO 13485:2016 certified. This formally acknowledges that we follow globally recognized standards. One of our defining goals at Aether Biomedical is to create a bionic hand for all. An important aspect of this goal is ensuring that all the safety protocols and regulations are strictly followed throughout the process.
ISO, which refers to the International Organization for Standardization, develops global standards to ensure the quality, safety, efficiency, and interoperability of products, services, and systems. There are various ISO standards for different industries and products. Out of these, ISO 13485:2016 is the internationally recognized quality management benchmark for medical devices and their manufacturers.
To achieve an ISO certificate therefore calls for meticulous auditing done periodically by a third-party certification body. The organization must prove it consistently meets the specific requirements of the required ISO standard. Aether Biomedical Quality Management System was certified by Tuv Nord Polska.
As ISO is an international body that develops global standards, Users can trust that Aether Biomedical is delivering high-quality products and services anywhere in the world as per the Quality Management System. ISO also ensures consistency, so users can count on the same quality level every time.
Users are strongly advised to avoid products or services without ISO certification. Choosing such a manufacturer and their service can put users at risk. Major concerns include uncertain quality, safety hazards, inconsistent results, poor performance, and potential legal issues.
At Aether Biomedical, ensuring quality and safety is a must and achieving ISO 13485:2016 certification is evidence of this commitment. We’re excited to move forward with this recognition, confident that it will further empower our users to live life without limitations.