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In order to determine whether your standalone software is considered to be a medical device it must first be determined what type of operating software is to be used. For example, is your software online software that runs through an internet browser, standalone…
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Medical device manufacturers who want to bring their devices onto the Union market, must understand three essential elements when complying to the MDD. Device manufacturers that want to enter into the EU Market need to understand three essential ideas: the role…
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Is my product a medical device (MD)? To know if your medical product falls within the scope of the CE marking legislation you must ensure if the product is classified as a medical device as defined in Directive 93/42/EEC. In the Medical Devices Directive (93/42/EEC)…
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The new European Union RoHS Recast Directive that comes into force on July 22 applies to all medical devices. The devices have to comply with some restrictions on certain metals that can become toxic and leach into groundwater, or become hazardous ash when incinerate….
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