CE

Risk Medical Solutions Ltd. is the manufacturer of the risk calculator that acquired a CE marking on its algorithm software solution in January 2013. Derived products from Risk Medical Solutions are legally verified CE marked by set quality standards within the European Economic Area.

The algorithm is classified as a “medical device” in category “I” and complies with the CE medical device directory. The standards listed below were considered to be applicable to medical software. However only standards number 5 (Application of risk management to medical devices), 6 (Software life-cycle processes) and 8 (Quality management systems – Requirements for regulatory purposes) were deemed necessary and purchased.

 

1. Symbols for use in the labelling of medical devices
Reference of harmonized standard: EN 980:2008
ESO: CEN

2. Information supplied by the manufacturer of medical devices
Reference of harmonized standard: EN 1041:2008
ESO: CEN

3. Clinical investigation of medical devices for human subjects – Part 1: General requirements (ISO 14155-1:2003)
Reference of harmonized standard: EN ISO 14155-1:2009

ESO: CEN

4. Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation plans (ISO 14155-2:2003)
Reference of harmonized standard: EN ISO 14155-2:2009
ESO: CEN

5. Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Reference of harmonized standard: EN ISO 14971:2009
ESO: CEN

6. Medical device software – Software life-cycle processes
Reference of harmonized standard: EN 62304:2006
IEC 62304:2006
ESO: Cenelec

7. Medical devices – Application of usability engineering to medical devices
Reference of harmonized standard: EN 62366:2008
IEC 62366:2007

8. Medical devices – Quality management systems - Requirements for regulatory purposes
Reference of harmonized standard: ÍST EN ISO 13485:2003

9. Quality management systems – Requirements
Reference of harmonized standard: ÍST EN ISO 9001:2008