ISO 13485 Documentation & implementation

If I understand the question correctly, you are asking is ISO 13485:2016 quality management system documentation the same for disposable medical devices and IVD devices. Yes, basic documentation is the same, the only difference is the procedures and work instructions for the production process (what kind of the production it is, is it necessary to produce them in the cleanroom or not, is there a sterilization process involved and similar).

For more details which documents are mandatory for ISO 13485:2016, please see the following links:

• List of mandatory documents required by ISO 13485:2016 - https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/
• Checklist of Mandatory Documentation Required by ISO 13485:2016 - https://info.advisera.com/13485academy/free-download/checklist-of-mandatory-documentation-required-by-iso-134852016
• How to structure Quality Management System documentation according to ISO 13485 - https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

On the following link, you can see how our ISO 13485:2016 documentation toolkit looks like - https://advisera.com/13485academy/iso-13485-documentation-toolkit/