Software as Medical Device Start-Up Template Package£2,200.00
If you are a start-up company developing an app or health software that could have an intended medical purpose, then you will need to consider the adoption of the recognized standard for Medical Device Software EN 62304: 2006+A1: 2015. The standard guides you to output a number of documents that can be used as Verification and Validation of the software in preparation for submission to the notified bodies or the FDA etc.
Pharmi Med has prepared these templates to help start-up companies who traditionally do not have Medical Device experience but usually from a Software Engineering background but need to penetrate the market. We have reduced the burden by creating these templates for your engineers. If you need further assistance in the regulatory framework of submissions please contact us here
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You may purchase the full package including instructions for use below.