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ISO 13485 Tools


Conformio – Free online tool for ISO compliance

Conformio is a smart online tool for ISO compliance – implement and maintain ISO 9001, ISO 14001, or ISO 27001 in your company with ease. Streamline your team effort with a single tool for managing documents, projects, and communication.


ISO 13485:2016 Gap Analysis Tool

Our free gap analysis tool helps you figure out which parts of ISO 13485:2016 you have already implemented, no matter if you are just beginning your implementation, or if you’re almost finished. The simple question-and-answer format allows you to visualize which specific elements of the Quality Management System you’ve already implemented, and what you still need to do.

This tool is conformant with the 2016 revision of ISO 13485, and best of all – you’ll get all the information without a big bill from a consultant!


ISO 13485:2003 vs 2016 Conversion Tool for Clauses

This free tool will help you to convert ISO 13485:2003 clauses to the new ISO 13485:2016 clauses. Just select the number of your current clause below and you will find out:

  • Which clause in ISO 13485:2016 corresponds with it.
  • What kind of changes do you need to perform in your Quality Management System for design and manufacture of medical devices to comply with the new revision of the standard.

Start your transition project right away, without an expensive consultant.

ISO 13485 Tools Designed to Make Your Life Easy

Here at the 13485Academy, we have created our whole service around the idea that you don’t need a costly consultant to hold your hand. You just need the right documents, the right Quality Management System for design and manufacture of medical devices tools and the right advice and you can easily implement ISO 13485 (and at a tenth of the cost).

These tools, together with a range of other free resources, are designed to give you the clarity and understanding you need to ensure a smooth, hassle-free implementation of the standard.


Strahinja Stojanovic
Lead ISO 13485 expert


Get free expert help with your
ISO 13485 documentation




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