Our Quality Management System (QMS) complies with the requirements of ISO 13485:2016 for the design and development of medical devices.
ISO 13485 is an internationally recognized quality management standard for medical device development, which is specifically designed to ensure that companies in the medical device industry are compliant with regulatory requirements, consistently producing high-quality products, and providing safe and effective products for patients.
Having an ISO 13485 certificate is essential for medical device development for several reasons. The ISO 13485 certification ensures that CLEIO has implemented an effective quality management system that meets regulatory requirements and is committed to continuous improvement. Medical devices are used to diagnose, treat, and monitor patients, and it is crucial that they are safe, effective, and reliable. An ISO 13485 certification indicates that our company has taken the necessary steps to ensure that the products we design are of the highest quality, meeting customer expectations and reducing the risk of product recalls or adverse events.
Our QMS and ISO 13485 certification helped streamline our processes and improved our overall efficiency. By implementing a quality management system that is compliant with ISO 13485, we can identify areas for improvement, reduce waste, and increase productivity. This, in turn, can lead to cost savings and increased profitability for our customers.