Showing all 2 results

  • Software as Medical Device Start-Up Template Package


    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

    You can preview the document below:

    You may purchase the full package including instructions for use below.

    Add to basketLoading Done
    Quick View CompareAdded
  • Validation Toolkit


    The Validation Toolkit is the answer to those who are either new to Validation, or those who want a simplified start to a validation approach. Pharmi Med Validations have used all their experience to piece together the essential components of a successful Validation system for both Medical Device and the Pharmaceutical industries; this toolkit will work.

    A 16-page preview of the Validation Toolkit is available here:

    Add to basketLoading Done
    Quick View CompareAdded