Does ISO 13485 apply to clinical CRO?

Yes, according to the ISO 13485:2016, in the section 1 Scope is stated that this standard is applicable for all organizations involved in one or more stages of the life-cycle of medical device, including design and development, production, storage and distribution, installation, servicing, design, and development or provision of associated activities.

For more information about that, please see the following articles:

• EU MDR Annex 15 – Clinical investigation https://advisera.com/13485academy/mdr/clinical-investigations/

For more information what is ISO 13485 and what will you get with it, please see following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
• 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/

Should you have any other question about this standard, do not hesitate to contact us.