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Distributor questionnaire 2023

Do you have...

A quality management system? (Please include certificate, if applicable)(Required)
An incoming goods procedure?(Required)
Inspection whether the products are clean and intact(Required)
Inspection of conformity of label (including CE-mark)(Required)
Inspection of presence of an EU-conformity declaration(Required)
Inspection of presence of information supplied with the device in Conformity with section 23 Annex I(Required)
A sampling procedure for performing incoming goods inspection(Required)
Procedures for storage and transportation of the medical devices under conditions that are in conformity with the product specification (see label)(Required)
Deviation and CAPA procedure(Required)
Recall procedure(Required)
Procedure for reporting serious risks or falsified devices under conditions that are in conformity with the product specification (see label)(Required)
A system for traceability of products in all stages (received, stored, sold)(Required)

if applicable

Approval by a notified body for activities performed. (Please include certificate if applicable)(Required)
A procedure for translations, which ensures that the translation of information is accurate and up-to-date(Required)
Procedure(s) for (re-)packing or (re-)labeling(Required)
Procedures ensuring that you are informed of any corrective action taken by Palmedic in relation to the device in question(Required)


Do you...
Make the devices of Palmedic available on the market under you own name, registered trade name or registered trade mark?(Required)
Make changes to the intended purpose of the device(s) of Palmedic?(Required)
Modify the devices of Palmedic (including primary packaging and labeling of primary packaging)(Required)
Modify the higher packaging layers of devices of Palmedic (including labeling of higher packaging layers)(Required)
Modify or translate the quality documentation of Palmedic (labeling and/or instructions for use)(Required)
Drop files here or
Accepted file types: jpg, gif, png, pdf, Max. file size: 512 MB.
    Please upload the following (if applicable): Certificate for; * Quality management system, * Approval by a notified body for activities performed

    Filled out by

    MM slash DD slash YYYY