RCSPC
Le résumé des caractéristiques de sécurité et des performances cliniques (RCSPC) pour les dispositifs médicaux de classe III Brainlab vise à fournir des informations directes à l’utilisateur prévu au sujet de la sécurité et des performances cliniques du dispositif médical en question. Le RCSPC résume l’évaluation clinique, les informations relatives à l’indication et aux contre-indications ainsi que les avertissements et risques liés au dispositif. Il contient en outre des informations sur la surveillance après commercialisation (SAC) et le suivi clinique après commercialisation (SCAC), et il est actualisé chaque année.
Le RCSPC n’a pas vocation à fournir des conseils généraux de diagnostic ou de traitement d’une affection médicale en particulier, ni à remplacer le mode d’emploi, qui demeure le document de référence garantissant l’usage du dispositif en toute sécurité, il ne remplace d’ailleurs aucun autre document obligatoire.
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Summary of Safety and Clinical Performance-EM Disposable Stylet DA
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Summary of Safety and Clinical Performance-EM Disposable Stylet HR
Summary of Safety and Clinical Performance-EM Disposable Stylet HU
Summary of Safety and Clinical Performance-EM Disposable Stylet IT
Summary of Safety and Clinical Performance-EM Disposable Stylet LT
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Summary of Safety and Clinical Performance-EM Disposable Stylet PL
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Summary of Safety and Clinical Performance - Disposable Suction BG
Summary of Safety and Clinical Performance - Disposable Suction CS
Summary of Safety and Clinical Performance - Disposable Suction DA
Summary of Safety and Clinical Performance - Disposable Suction DE
Summary of Safety and Clinical Performance - Disposable Suction EL
Summary of Safety and Clinical Performance - Disposable Suction EN
Summary of Safety and Clinical Performance - Disposable Suction EP
Summary of Safety and Clinical Performance - Disposable Suction ES
Summary of Safety and Clinical Performance - Disposable Suction ET
Summary of Safety and Clinical Performance - Disposable Suction FI
Summary of Safety and Clinical Performance - Disposable Suction FR
Summary of Safety and Clinical Performance - Disposable Suction HR
Summary of Safety and Clinical Performance - Disposable Suction HU
Summary of Safety and Clinical Performance - Disposable Suction IT
Summary of Safety and Clinical Performance - Disposable Suction LT
Summary of Safety and Clinical Performance - Disposable Suction LV
Summary of Safety and Clinical Performance - Disposable Suction NL
Summary of Safety and Clinical Performance - Disposable Suction PL
Summary of Safety and Clinical Performance - Disposable Suction RO
Summary of Safety and Clinical Performance - Disposable Suction SK
Summary of Safety and Clinical Performance - Disposable Suction SL
Summary of Safety and Clinical Performance - Disposable Suction SV