I would like to ask about the documents included with the "ISO 13485 & MDR Integrated Documentation Toolkit toolkit with expert support"
We are a company with class I medical devices and are in the process of creating the SOPs to be compliant with MDR
Are your SOPs geared towards medical devices with higher classes (therefore more detailed and technical) or are they also suitable / can be modified for class 1 devices
For class 1 medical devices, we need to do SOPs for regulatory strategy; final product release; vigilance; and field safety corrective action. I don't seem to see those in the list of SOPs via the preview, and wanted to check if those are included or under a different name?
Also, does your company provide a way to identify in the SOPs which part of the relevant SOP is necessary for Class 1, and which parts are not? As we will likely only want to include the necessary info and not give extra unnecessary info.