By browsing our ProtecSom website, you may have read that our anti-dust mite covers are manufactured under the ISO 13485:2016 process. To our knowledge, we are currently the only European manufacturer of anti-dust mite certified by this standard.
But what does that actually mean?
ISO 13485:2016 is a set of international rules that ensure the quality of medical device development processes. These rules apply to all stages, from design to manufacturing and sales, to ensure that devices are safe and effective.
A guarantee of quality
The ISO 13485:2016 standard guarantees that safety and performance parameters are taken into account during the design and manufacture of our devices. By choosing our ProtecSom anti-dust mite covers, you benefit from the assurance that our products meet the strictest safety and performance standards. Furthermore, each batch of textiles used in our covers undergoes rigorous testing.
The guarantee of traceability
The ISO 13485:2016 standard requires traceability procedures to track the manufacturing, packaging, and distribution of our products. These rigorous traceability procedures guarantee that each step is precisely controlled and monitored. You can therefore have confidence in the origin and quality of our anti-dust mite covers.
Safe devices
By adhering to the strict standards of ISO 13485:2016, we take a proactive approach to identifying and managing any potential health risks associated with our products. Manufacturing under this process ensures that our anti-dust mite covers are safe for you and your family.
A commitment to continuous improvement
By choosing a ProtecSom anti-dust mite cover manufactured according to the ISO 13485:2016 process, you are choosing a product that is constantly improving. We are committed to continuous improvement to better meet your needs and guarantee your satisfaction, both in our manufacturing processes and in the quality of our products.