ISO13485: Marketing materials and design files

I work at a startup as a QA/RA and am working on document control. I am trying to figure out which marketing and design documents needed to be controlled and reviewed according to ISO13485. To which type, what information needs to be controlled.
Can anyone help me? Thank you

 

Generally, anything with claims should be controlled (including your website / pages!). I'd suggest that you (as regulatory) review everything, at least, to determine if it qualifies for control.

 

Thank you for your suggestion

 

When working on document control under ISO 13485, marketing and design materials that make any claims about the product's safety, performance, or intended use generally need to be controlled. Anything that speaks to regulatory requirements or gives consumers information that could influence their use of the product might fall under this.From my experience, using a service can help with building compliant marketing materials. They understand the nuances of keeping messaging aligned with regulations while helping with creative aspects.