Company Logo
Amanda Coy
1 Posts
Hello! I was wondering if anyone had any guidance on whether it is required to release your company logo on a change order prior to using it. (Medical Device Class III) It's always been that way at my current place of employment but this company I am consulting with has a consulting quality group as well saying it is not required. This is not the first time they have gone against the quality system at this company which is why I am curious. Is this a preference thing or a requirement that they are incorrect about?
2 Replies
Interesting question. I don't have a direct answer for it, but looking from the eyes of an auditor, I would like to see traceability to the change such as: Who reviewd it? approved it? Is it compliant to EUMDR? why did the logo change happen? etc, etc. Maybe there are other places to record it, like management review minutes if it is a simple logo update. I know that in my case (Medical device class 2A) when we change any information on the product or shipping labels (like a logo size for example), ECR/ECOs affect everything that has that updated logo or new information. So, my guess is that even if you don't release it through ECR/ECO, there will be a cascading effect to update everything else eventually. Check with your Regulatory Affairs or Tech Pubs department to see what ISO13485 requires. A good auditor may ask for clarification during an audit.
Hi Amanda. While a change in the company logo may not require a change order, if the new/revised logo is used on the product or in promotional materials, any change will definitely require it. Regulatory bodies will certainly look at change orders related to labeling changes and promotional materials. In my experience, I have seen more emphasis by auditors on labeling and promotional materials.