As of 24 May, 2024 European regulations for medical devices have changed.
SilverFit’s medical products meet these new MDR requirements for CE marking. Our way of working follows standards for medical products such as ISO 13485 for quality management (certified) and IEC 62304 for software development (not certified) among others.
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This means, for example that:
– all exercises are tested against guidelines and scientific insights;
– we identify and address risks per exercise;
– we keep track of all changes to the systems;
– we regularly collect input from our users on how we can improve further.
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 externally audited and certified ISO 13485 the international standard for quality management for medical products.
Declaration of conformity (DoC)
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.
Here you can find the declaration of conformity of our systems:
- Declaration of conformity of the SilverFit Mile
- Declaration of conformity of the SilverFit 3D
- Declaration of conformity of the SilverFit Newton
- Declaration of conformity of the SilverFit Flow
- Declaration of conformity of the SilverFit Rephagia
- SilverFit Alois is not a medical device and therefore has no certification.
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 the for all information about us as a manufacturer and about the SilverFit systems:
- EUDAMED database on the SilverFit Mile
- EUDAMED database on the SilverFit 3D
- EUDAMED database on the SilverFit Newton
- EUDAMED database on the SilverFit Flow
- EUDAMED database on the SilverFit Rephagia
- SilverFit Alois is not a medical device and therefore has no certification.
