ISO 13485 is an international standard for quality management systems for the design and manufacture of orthopedic devices.
It provides a framework to ensure that products meet customer requirements, are safe to use, and comply with applicable laws and regulations.
By choosing ISO 13485, companies can alleviate the burden of complex legislation. Moreover, it enables them to collaborate with other organizations, such as hospitals and healthcare facilities. Additionally, it ensures that the quality of products is consistently maintained at a high level and patient safety is ensured.
ISO 13485 certified company
Quality Production is an ISO 13485 certified company.
Our 6000 m² - ISO 13485 certified - production facility adheres to the highest standards for customizing orthoses, prostheses, corsets, and orthopedic insoles.
We guarantee ISO 13485 quality and MDR compliance. Quality management is a requirement from government authorities, hospitals, and healthcare centers that take pride in their JCI, NIAZ, KIWA, or other quality certifications.
Each device manufactured by us is delivered with a unique passport that ensures traceability of materials.
In summary, ISO 13485 sets high standards for quality assurance in the production of orthopedic devices and provides assurance that products are safe and comply with all relevant regulations.