This repository contains content relevant to the application for ISO 14971. I'm sick of having to re-write this from scratch repeatedly.
Italicized content in the documents is contextual information and should be removed as appropriate.
Use pandoc to generate documentation from the markdown files. For example
pandoc .\docs\risk-management-plan.md -o risk-management-plan.pdf --template=document-template.tex
Will convert the risk management plan to a pdf using the template found in this repo.
This is a template for a risk management plan that complies with the requirements of ISO 14971: 2019.