J
Hi Experts!
We recently had a TUV audit at our organization and they found that we are not very well associating our devices with their corresponding IFUs.
Another problem is the name of our device on DOC does not match with what is on IFU AND we have 20 part numbers for different devices on DOC but only 10 of them are covered in IFUs.
What we intepret as a problem here because of the weak association or lack of traceability (for many part numbers) the customer might receive no IFU with a product, which could be a potential hazard AND other problem is how does TUV know if all the devices that we are marketing are covered under the DOC (since the names and part numbers do not match)
So what would be a proposed solution for this which does not require too many revisions. Can we solve this by having consistent names of devices on our IFUs and DOC?
i refer the follwing website for all guidance documents for EU regulations.
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
Could you please suggest another website where I could find all guidance documents of EU requirements and if you could let me know any specific guidance for labeling (IFU) for medical devices that would be awesome!
Thank you so much,
I look forward to your valuable feedback
Jen
We recently had a TUV audit at our organization and they found that we are not very well associating our devices with their corresponding IFUs.
Another problem is the name of our device on DOC does not match with what is on IFU AND we have 20 part numbers for different devices on DOC but only 10 of them are covered in IFUs.
What we intepret as a problem here because of the weak association or lack of traceability (for many part numbers) the customer might receive no IFU with a product, which could be a potential hazard AND other problem is how does TUV know if all the devices that we are marketing are covered under the DOC (since the names and part numbers do not match)
So what would be a proposed solution for this which does not require too many revisions. Can we solve this by having consistent names of devices on our IFUs and DOC?
i refer the follwing website for all guidance documents for EU regulations.
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
Could you please suggest another website where I could find all guidance documents of EU requirements and if you could let me know any specific guidance for labeling (IFU) for medical devices that would be awesome!
Thank you so much,
I look forward to your valuable feedback
Jen