Clean room criteria for ISO 13485

Thank you for the question. There is a lot of things that need to be taken into consideration when wanting to get an ISO 13485:2016 certificate. For the documentation, you can use our Documentation toolkit which has all necessary and required documentation from the standard. Prices and what is contained in the toolkit at the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

More information on the ISO1 3485, you can find on the following links:

• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
• Checklist of ISO 13485 implementation 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/