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AAMA
AIMD
Accessory for a medical device
Accessory to a medical device
Active implantable medical device
Active implanted medical device
American Amusement Machine Association
Amusement Device Manufacturers Association
Amusement Game Manufacturers Association
Biomedical device
Biomedical equipment
Canada's Medical Device Technology Companies
Canada's Medical Technology Companies
Device used for in vitro diagnosis
Implant
In vitro diagnostic medical device
MEDEC
Manufacture medical devices
Medical Devices Canada
Medical and surgical equipment
Medical and surgical instruments
Medical apparatus
Medical appliance
Medical device
Medical device manufacture
Medical device monitoring
Medical device reporting
Medical device surveillance
Medical device test procedures
Medical device testing methods
Medical device vigilance
Medical equipment
Medical instrument
Medical scanner
Medical supplies
Medical technology
Procedures for testing medical devices
Produce medical devices
Prosthesis
Surgical device
Surgical instrument
Surgical material
Test a medical device
Test medical devices
Test procedures for medical devices
Testing a medical device
Therapeutic equipment
Try medical devices

Traduction de «medical device manufacture » (Anglais → Français) :

TERMINOLOGIE
voir aussi les traductions en contexte ci-dessous
manufacture medical devices | medical device manufacture | manufacture medical devices | produce medical devices

fabriquer des dispositifs médicaux


medical device [ biomedical device | biomedical equipment | implant | medical and surgical instruments | medical apparatus | medical appliance | medical equipment | medical instrument | medical scanner | prosthesis | surgical device | surgical instrument | surgical material | therapeutic equipment | Medical and surgical equipment(ECLAS) | Medical technology(STW) | medical supplies(UNBIS) ]

matériel médical [ appareil médical | dispositif médical | équipement biomédical | équipement médical | équipement thérapeutique | implant | instrument médical | matériel biomédical | matériel chirurgical | matériel médico-chirurgical | prothése | scanner médical ]


testing a medical device | try medical devices | test a medical device | test medical devices

tester des dispositifs médicaux


medical device testing methods | test procedures for medical devices | medical device test procedures | procedures for testing medical devices

procédures d’essai de dispositifs médicaux


accessory for a medical device | accessory to a medical device

accessoire de dispositif médical


active implantable medical device | active implanted medical device | AIMD [Abbr.]

dispositif médical implantable actif


device used for in vitro diagnosis | in vitro diagnostic medical device

dispositif destiné au diagnostic in vitro | dispositif médical de diagnostic in vitro


American Amusement Machine Association [ AAMA | Amusement Game Manufacturers Association | Amusement Device Manufacturers Association ]

American Amusement Machine Association [ AAMA | Amusement Game Manufacturers Association | Amusement Device Manufacturers Association ]


Canada's Medical Technology Companies [ MEDEC | Medical Devices Canada | Canada's Medical Device Technology Companies | Canadian Association of Manufacturers of Medical Devices ]

Les Sociétés canadiennes de technologies médicales [ MEDEC | Instruments médicaux Canada | Association canadienne des fabricants d'équipement médical ]


medical device reporting [ medical device vigilance | medical device monitoring | medical device surveillance ]

matériovigilance
TRADUCTIONS EN CONTEXTE
8.7a. Medical device manufacturers shall notify their users of the levels of disinfection required to ensure patient safety and of all available methods for achieving those levels of disinfection.

8.7 bis. Les fabricants de dispositifs médicaux doivent informer leurs utilisateurs des niveaux de désinfection permettant d'assurer la sécurité des patients, et de toutes les méthodes disponibles permettant d'atteindre ce niveau.


(25a) To ensure that patients harmed are compensated for any damage and associated treatment as a result of a faulty medical device, that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by a faulty medical device, manufacturers should be obliged to take liability insurance with sufficient minimum coverage.

(25 bis) Pour garantir que les patients ayant subi des préjudices du fait de dispositifs médicaux défectueux sont indemnisés de tout dommage et traitement associé, et éviter que le risque de dommage du fait d'un dispositif médical défectueux et le risque d'insolvabilité du fabricant ne retombent sur les patients en cas de préjudices, les fabricants devraient être obligés de souscrire une assurance en responsabilité civile, assortie d'une couverture minimale suffisante.


(25a) To ensure that patients harmed are compensated for any damage and associated treatment as a result of a faulty in vitro diagnostic medical device, that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by a faulty in vitro diagnostic medical device, manufacturers should be obliged to take liability insurance with sufficient minimum coverage.

(25 bis) Afin de garantir que les patients ayant subi un préjudice soient indemnisés de tout dommage et de tout traitement associé du fait d'un dispositif médical de diagnostic in vitro défectueux et que le risque de dommage et le risque d'insolvabilité du fabricant ne retombent pas sur les patients ayant subi un préjudice du fait d'un dispositif médical de diagnostic in vitro défectueux, les fabricants devraient avoir l'obligation de souscrire une assurance de responsabilité civile ...[+++]


(39) For high-risk medical devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.

(39) Pour les dispositifs médicaux à haut risque, il convient que les fabricants en résument les principales caractéristiques de sécurité et performances et les résultats de l'évaluation clinique dans un document destiné à être rendu public.


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(32) For high-risk in vitro diagnostic medical devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available.

(32) Pour les dispositifs médicaux de diagnostic in vitro à haut risque, il convient que les fabricants en résument les principales caractéristiques de sécurité et performances et les résultats de l’évaluation clinique dans un document destiné à être rendu public.


In order to satisfy the legal requirements laid down in Directive 90/385/EEC, in Directive 93/42/EEC and in Directive 98/79/EC, notified bodies should verify, where relevant, the fulfilment of the essential safety and health requirements contained in Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC , of the requirements contained in Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices a ...[+++]nd medical devices manufactured utilising tissues of animal origin and of the common technical specifications for in vitro diagnostic medical devices laid down in Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices

Pour satisfaire aux prescriptions définies dans les directives 90/385/CEE, 93/42/CEE et 98/79/CE, les organismes notifiés devraient contrôler, le cas échéant, le bon respect des exigences essentielles en matière de santé et de sécurité fixées par la directive 2006/42/CE du Parlement européen et du Conseil du 17 mai 2006 relative aux machines et modifiant la directive 95/16/CE , des obligations figurant dans le règlement (UE) no 722/2012 de la Commission du 8 août 2012 relatif aux prescriptions particulières en ce qui concerne les exigences prévues aux directives 90/385/CEE et 93/42/CEE du Conseil pour les dispositifs médicaux implantables actifs ...[+++]


In order to maintain a high level of safety and health protection against the risk of transmitting animal spongiform encephalopathies to patients or other persons via medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable, including custom-made devices and devices intended for clinical investigation, it is necessary to update the rules laid down in Directive 2003/32/EC on the basis of the experience with the application of this Directive and to apply them also to active implantable medical devices manufactured ...[+++]

Afin de maintenir un niveau élevé de sécurité et de protection de la santé contre le risque de transmission d’encéphalopathies spongiformes animales à des patients ou à d’autres personnes par l’intermédiaire de dispositifs médicaux fabriqués à partir de tissus d’origine animale non viables ou de dérivés rendus non viables, notamment des dispositifs sur mesure et des dispositifs destinés à des investigations cliniques, il est nécessaire de mettre à jour les règles prévues à la directive 2003/32/CE sur la base de l’expérience acquise lors de la mise en œuvre de ladite directive et de les appliquer également aux dispositifs médicaux implant ...[+++]


(1) In addition to being directed at medical devices for in vitro diagnosis, the Commission proposal sought to amend Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(4) in order to extend its scope to medical devices manufactured by using non-viable tissues or substances of human origin derived from those tissues.

(1) La proposition de la Commission visait, outre les dispositifs médicaux de diagnostic in vitro, une modification de la directive 93/42/CEE du Conseil du 14 juin 1993 relative aux dispositifs médicaux(4), de manière à étendre son champ d'application aux dispositifs médicaux fabriqués en utilisant des tissus non viables ou des substances d'origine humaine dérivées de ces tissus.


Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212 of 9.8.2012, pp. 3-12)

Règlement (UE) n 722/2012 de la Commission du 8 août 2012 relatif aux prescriptions particulières en ce qui concerne les exigences prévues aux directives 90/385/CEE et 93/42/CEE du Conseil pour les dispositifs médicaux implantables actifs et les dispositifs médicaux fabriqués à partir de tissus d’origine animale (JO L 212 du 9.8.2012, p. 3-12)


Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Official Journal L 212, 9.8.2012, pp. 3-12)

Règlement (UE) n 722/2012 de la Commission du 8 août 2012 relatif aux prescriptions particulières en ce qui concerne les exigences prévues aux directives 90/385/CEE et 93/42/CEE du Conseil pour les dispositifs médicaux implantables actifs et les dispositifs médicaux fabriqués à partir de tissus d’origine animale (JO L 212 du 9.8.2012, p. 3-12)




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Date index: 2023-10-30
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