ISO 13485 certified company
Quality Production is an ISO 13485 certified company.
Our 6,000 m² ISO 13485-certified production facility meets the highest standards for the custom manufacturing of orthoses, prostheses, corsets and insoles.
We guarantee ISO 13485 quality and MDR compliance.
Quality management is required by the government, and by hospitals and health centres that are proud of their JCI, NIAZ, KIWA or other quality marks.
Every device we make is delivered with a unique passport that guarantees the traceability of the materials.
In short, ISO 13485 sets the bar high for quality assurance in the production of orthopaedic devices. It gives you the assurance that products are safe and comply with all relevant regulations.
ISO 13485 is an international standard for quality management systems for the design and manufacture of orthopaedic 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 be relieved of complex legislation. It also allows them to work with other organisations, such as hospitals and care institutions. In addition, it ensures that product quality is consistently kept at a high level and that patient safety is guaranteed.
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