CE mark according to MDR for SilverFit Newton

CE mark according to MDR for SilverFit Newton

CE Mark:

The CE mark indicates that our software complies with European product legislation for medical products. This mark is mandatory for products used for medical or therapeutic purposes. The new MDR rules require, for example, that we have a sound scientific basis for the products, that a strict process is followed in programming and testing, that a risk assessment is carried out and that we collect information on how the products can be improved. As part of this process, SIlverFit is also ISO certified and externally audited to the ISO 13485 standard for medical products.

Declaration of conformity:

A declaration of conformity (DoC) is an official certificate in which the manufacturer declares that its product complies with the essential requirements of the applicable European CE directives and/or regulations. This document is mandatory because it is required to certify that the product complies with the CE marking.

Download the document declaration of conformity of the SilverFit Newton.

EUDAMED:

EUDAMED is the European Database on Medical Devices. This database contains information on medical devices and manufacturers, for example on CE marking, clinical trials and instructions for use of a product.

Visit the EUDAMED database on the SilverFit Newton for all information about us as a manufacturer and about the SilverFit Newton system.