Commit to Quality
Does your clinic conform with EU safety directives?
In the EU Tissues and Cells Directive (Directive 2004/23/EC), rules about the donation, procurement and testing of human tissues and cells (including reproductive cells) are given. In the Directive 2006/17/EC it is stated that “Whenever possible, only CE marked medical devices must be used”.
We care about patient safety. LinnéFiler meets the requirements of the European Medical Device Directive. Behind every new release of LinnéFiler there is extensive testing, documentation and risk analysis, covering all steps of the product development phase. Currently, LinnéFiler is the only IVF software that is CE marked.
Safety measures include:
- Traceability of recording and editing of patients
- Traceability of materials and equipment used in treatment of cells
- Only authorized users can perform certain actions