Requirement of ISO 13485

If your device is a medical device according to the definition stated in the Medical device regulative (MDR 2017/745), then ISO 13485:2016 is applicable for you. ISO 13485:2016 is the only harmonized standard that is covering quality management system, and each manufacturer has an obligation to show compliance with applicable harmonized standards. 

For the definition see:

• EU MDR Article 2 Definitions https://advisera.com/13485academy/mdr/definitions/ 

For the use of harmonized standard please refer to the following article

• EU MDR Article 8 – Use of harmonized standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/

If you need any help for the implementation of the ISO 13485:2016, these materials can help

• 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/

You can see our ISO 13485:2016 DOcumentation toolkit on following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/