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The EUropean DAtabase on MEdical Devices (EUDAMED) is a database to collect and publish information on medical devices and in-vitro-diagnostica. EUDAMED has six modules: Actors registration; UDI/Devices registration; Notified Bodies and Certificates; Clinical Investigations and performance studies; Vigilance and post-market surveillance; Market ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
As a non-EU manufacturer of medical devices, the manufacturer's legal representative must appoint a "responsible individual person or company" to register their product with the Italian database. The official form needed is available here: This "responsible individual person or company" will communicate with the Italian Ministry of Health on ...
Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
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The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
Drug and medical device testing: Scientific review of market authorization applications based on Japanese pharmaceutical law; Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA))
EASA wrote a certification memoranda to require the use of DO-254 for all complex electronics within a system, stating that all equipment and CBA with a Design assurance classification of A, B, C or D should meet level D objectives for the equipment and CBA, regardless of the DAL of the system or aircraft function.
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