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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!
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:
Start your transition project right away, without an expensive consultant.
Here you can find the official text of the Regulation (EU) 2017/745 (Medical Device Regulation) arranged by chapters, sections, and articles.
The Medical Device Regulation will be applicable as of 26 May, 2021, in all member states for any company that manufactures, imports or distributes medical devices within EU states.
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.
Kristina Zvonar Brkic
Lead ISO 13485 expert
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ISO 13485 documentation
