DICOM/PACS viewer certification in Europe

[Maikel Zweerink]

Hi fokes,

During my internship i created an lightweight PACS/DICOM viewer. Now that i'm finished with this project the company wants to certificate this viewer and use in the medical field.

However, i cant find any documentation about the requirements. I thought you'd might know some more about these requirements (for example screen kalibration?) and where i can find those.

Thanks in advance,

Maikel

[Michael Knapp]

The company is required to be ISO 13485 certified: http://en.wikipedia.org/wiki/ISO_13485

[Alessandro Neri]

http://en.wikipedia.org/wiki/IEC_62304

[Maikel Zweerink]

Thanks for your reply, but i cant really figure out what this means.

Is it required to have certification when the viewer is only used for reviews?

[Arnold Maderthaner]

I think thats depending on your country but in most afaik you need to have a CE certificate also for reviewing.