NiktoneClient

In this website we have all documentations for the Niktone client/Tolid application developed for HAD devices at NIKTED.
Here is a description of the folders:

IEC62304

At the root of this folder, you can find the mapping of IEC62304 requirements to our processes and documents, which is the root documentation and a good starting point to understand how we comply with the standard. In this doc, each section of the standard is mapped to one or more documents that you can find in the records folder.

summary folder

Here you can find helpful summaries for the IEC62304 standard.

templates

These are outlines and descriptions that can be used as a template for new projects aiming to have IEC602304 standard at NIKTED.

records

Implementations of templates for the NiktoneClient application, which map to the requirements of IEC62304.