When it comes to quality and reliability Pressalit A/S has high ambitions. Not only do our products comply with all statutory requirements regarding assistive products to obtain the CE marking.
We also take pride in going a step further in order to obtain an extra mark of quality, a certification by the accredited and highly reputable German test lab, TÜV SÜD.
Thus, all our PLUS support arms have recently been certified by TÜV in accordance with standard ISO 17966, a relatively new standard for assistive products from 2016.
“Obtaining the TÜV certification is a big deal within healthcare-products. The certification signifies very high quality and hopefully this will end up having an impact on sales in certain markets as well”, says Kim Boyter, CEO at Pressalit A/S.
Product Management Coordinator, Trine Danielsen, adds to this;
“The TÜV-mark indicates certification by a neutral third party – as opposed to a declaration made by ourselves. TÜV has tested the products rigorously and scrutinized all of our internal and external documentation. A factory inspection is also part of the certification, and here they verify all our practices and procedures. This emphasizes our focus on reliability and high quality and consequently we expect it to open the way for Pressalit A/S to new markets in the world.”
The CE marking is recognized worldwide. However, in some countries, like the US, we also apply to further required standards.
Moreover, we continually strive towards obtaining more certifications for our products in order to demonstrate their quality and comply with the given regulations in the various markets we operate in.
ISO 17966 regards assistive products for personal hygiene that support users – Requirements and procedures.
The standard contains both functional requirements, test methods and requirements for documentation supplied by the manufacturer (e.g. user manual, installation instructions, etc.).