Preparing the documentation
I have limited experience in ISO 13485 and I am trying to get the documentation ready for certification. I don't know where to go. I am doing most of the documents by myself and I am overwhelmed. Is there something that can help me figure out what documents align to what clause IE New product Inspections? What procedures and records I need to create and how to figure out what I am missing.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
You can see how our ISO 13485:2016 documentation toolkit looks like on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/
You can even download the free demo on the following link: https://advisera.com/13485academy/iso-13485-free-demo/
For more information on what is ISO 13485:2016 please see the following links:
- What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
- Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
- Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
- 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/
If you will have any other questions regarding the ISO 13485, please do not hesitate to contact us.
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Nov 06, 2020