standards

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A guide to the Dutch sustainable certification jungle in food

In the beginning of the new calendar year, people tend to stick to new year’s resolutions, such as eating healthier. In supermarkets and other stores choosing healthy/ sustainable products is made easy…

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Team NB FAQ on EN62304 standard for software lifecycle processes

Many companies developing medical software, especially the smaller app developers, have difficulties applying the EN62304 standard. For that reason a number of experts under the auspices of Team NB started work on…

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Regulating Medical Software and nothing new on the Recast

Today I attended the COCIR workshop Regulating Medical Software in Brussels, a very interesting event that brought a lot of new information to my attention and I had the opportunity to speak…

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Standardisation, anyone?

Today I attended the NEN (Nederlands Normalisatie instituut (Dutch Standardisation Institute)) meeting about “Software and the MDD”, where I presented about recent developments in software and the MDD (apologies to the English…

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ISO 14155:2011 is here: revised standards for medical devices clinical trials

ISO 14155, who in medical devices  is not familiar with that standard with respect to clinical investigation of medical devices for human subjects? Not that long after the EU had harmonised the…

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New standard for medical technology used at home

Earlier this month the EU published a new notice of standards harmonised under the three medical devices directives. Although this in itself is news, I would like to put the spotlight on…

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Software design for medical devices

I just returned from an interesting conference in Munich about software design for medical devices. I had the privilege to present on legal issues and some regulatory issues related to software and…

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New EU competition rules on R&D, information exchange and standards

The European Commission has revised its rules for the assessment of co-operation agreements between competitors, so called horizontal co-operation agreements. The most important changes for the medical devices industry are in the…

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