Artwork and labelling
Artworks and labels form part of your medical device technical file. If an artwork or label is changed the corresponding section in the technical file needs to be updated.
QbD’s experts will help you getting it right.
Ensure compliancy
IFU(s) and label texts are part of the product which come into direct contact with the consumers.Â
It must be stressed that non-compliant artworks and labels can be the cause of serious compliance issues, which in the worst case can lead to batch and/or product recalls. Batch and/or product recalls could cost a company millions.
QbD’s consultants will make sure your artwork and labelling are fully compliant.
How we support you
- Prepare compliant Instructions for Use (IFUs) and label texts
- Oversee texts translation projects
- Check IFUs and Labels texts for compliance
- Check artworks and labels for regulatory compliance
- Advise on the use of symbols based on EN 980
Why QbD Group?
Benefit from our team of highly qualified consultants. ​
Full support from pre- to the post-marketing phase.​
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.​
Constant evaluation, transparency and clear objectives.​
Contact us
Contact us for more information or to request a free, no-obligation proposal.
