Tag: software
Best Free Antivirus Software of 2026
If you have a laptop or personal computer, it is important to make sure you are protected by antivirus software. These programs protect your device by identifying, blocking, or removing malicious software, or “malware,” that can cause harm to your device if it is not detected and removed in time. In this article, we Agen…
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Software als Medizinprodukt SaMD: Definition und Klassifizierung
Unter Software als Medizinprodukt (Software as Medical Device, SaMD) versteht man (eigenständige) Standalone-Software, die ein Medizinprodukt ist, aber nicht Teil eines solchen. Sie ist nicht zu verwechseln mit Medical Device Software im Sinne der EU. Wann müssen Sie als Hersteller Software als Medizinprodukt und wann als Medical Device Software qualifizieren? Das erfahren Sie hier – und können…
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Document Control ~ Software, QM ~ Document Control
Under Document control it is a documented process that determines how documents are created, reviewed, approved, labeled, distributed and updated. Organizations certified according to ISO 9001 or ISO 13485 are obliged to maintain document control. 1. Object of the document control It is obvious that document control is about documents. What is less obvious is…
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Test di regressione: la tua assicurazione software
I tester del software solitamente intendono un test di regressione come la ripetizione di un test esistente. Vuoi verificare se questo test funziona ancora con successo dopo una modifica del software. Leggi questo articolo su cosa dovresti considerare quando conduci un test di regressione per un software medico. 1. Obiettivi dei test di regressione Obiettivo…
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