Software Decision Diagram – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 20 Apr 2011 18:42:40 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Software Decision Diagram – Eisner Safety Consultants https://eisnersafety.com 32 32 COCIR Issues Flowchart to determine if Software = Med Dvc per MDD https://eisnersafety.com/2011/04/20/cocir-issues-flowchart-to-determine-if-software-med-dvc-per-mdd/?utm_source=rss&utm_medium=rss&utm_campaign=cocir-issues-flowchart-to-determine-if-software-med-dvc-per-mdd Wed, 20 Apr 2011 18:42:40 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2110 COCIR, the European industry association representing the radiological, electromedical and IT industries, issued (on 22 Nov 2010) a decision diagram to determine if software is considered a medical device per the Medical Device Directive (MDD) 93/42/EEC including the amendment.  The document includes a clear definition of what software includes, which is a wide range of items.  Refer to the footnotes for some details that refer back to the MDD.

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