Article R5211-45
…cedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the manufacture of his medical devices. The approv…
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Showing 6131–6140 of 24518 articles for “Art. CA Reims – 4 Oct. 2010”
…cedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the manufacture of his medical devices. The approv…
In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees…
…he EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an application to…
…procedure, product quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the final inspection of medical devices and in par…
The official veterinarians mentioned in 3° of article L. 5146-2, sworn in under the conditions defined in article R. 205-1 of the rural and maritime fishing code and authorised to investigate and reco…
…cedure, the manufacturer must submit to an authorized body for examination a representative sample, called a type, of the production envisaged in order that the body may check that this sample satisfi…
As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with…
…s, the dissemination of advertising which is manifestly contrary to the provisions of articles R. 5141-82 to R. 5141-88.
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
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