Allen Software

Posts Tagged ‘dicos’

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Saturday, January 31st, 2015

All those involved in the process of translation and localization of medical software (translators, agencies and manufacturers or developers) must be clear what is a health product according to the applicable European legislation: health product: sanitary product is considered any instrument, device, equipment, program computer, material or other article, used alone or in combination, including the software intended by its manufacturer for specific purposes of diagnosis or therapy and involved in its functioningintended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of an illness, diagnosis, control, treatment, relief or compensation for an injury or a deficiency, investigation, replacement or modification of the Anatomy or of a physiological process, control of conception, and which does not exercise the primary action that you want to get in the inside or on the surface of the body human by pharmacological, immunological or metabolic means, but which function can contribute such means. Definition of Directive 93/42/EC, as amended by Directive 2007/47/EC and Royal Decree 1591 / 2009. I.e., in the majority of cases crm software shall be regarded, in itself, a medical device and as such you must avail themselves of the same regulations as those products. Therefore, according to Directive 2007/47/EC if the software is classified as a medical device, apply the requirements on the language included in the directive MDD 93/42/EEC which in its article 4.4, annex I, paragraph 13.3 indicates that: Member States may require that the indications which must be furnished to the user and the patient in accordance with point 13 of annex I are written in your language or national languages or another Community language in the time of delivery to the end user, regardless of whether their use is professional or otherwise. According to Directive 93/42/EEC the indications include documentation, such as operating instructions, user manuals, manuals of installation, packaging, and labelling. Additionally, for the software lawyers classed as medical device Directive 2007/47/CE, the indications would include the graphical interface (GUI) user, menus, dialog boxes, messages of error and status, the online help, etc. However, some manufacturers of sanitary products will try to argue that users of the software know languages other than the official of the State in which the product is marketed, however this excuse is not valid in any way because there is no reliable way to argue that each and every one of the users of such software are aware enough well the language in which is presented as to eliminate any risk for health, own or patients. If necessary, before more usual, that a client ask us to let the software in English (or German, or) French, etc) while it only intends to translate the help, must argue with data our opposition to such a practice and remind him, in order to not violate the law, should reconsider its position and proceed in the most natural and structured way to the translation and localization of your product: the first interface and subsequently help and printed documentation. To be able to argue more forcefully, or for those who wish to read the documents mentioned in this entry, I leave these documents to your consultation or download in my public Dropbox folder.