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Keeping, maintaining and updating your technical files

For answering to European Competent Authorities requests in terms of European availability and product notification/registration, we request you a list of documents from your Technical file.

These documents are treated with the highest confidentiality under our own certified quality system. This information is also important for helping us to better understand your company and products. We are always happy to receive additional training information and to visit you at your manufacturing site.

We send to you regularly, a reminder asking if you have any change in product design, distributor list, labels, IFU, etc… for updating your files.In case that an European Competent Authority requests documents that we have not in our file, we will ask you to send them within 48 hours. Of course, you receive a copy of any letter sent to or received from Competent Authorities.

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