Quality | Ellen

Quality

Ellen’s highest priority is to be able to ensure a high level of consumer safety and product quality. That is why we always strive to provide reliable and high-quality products produced from carefully selected raw materials.

ISO 13485 is a standard for quality management of medical devices. As part of our quality work, we have chosen to certify ourselves according to ISO 13485 for the manufacture and distribution of our probiotic tampons. Although our probiotic tampons are not classified as medical devices but as consumer products.

For our cosmetic products, we follow current regulations and ordinances from the Medical Products Agency and the EU. All our cosmetic products are also manufactured in accordance with ISO 22716.

Our medical devices comply with EU directives and ISO 13485.