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  • 14 July 2017

    CE-marking medical software

    When does medical software need a CE certification? Medical devices, such as infusion pum

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  • 29 April 2016

    Context Help in Web Applications

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  • 21 July 2015

    NEN 5509

    Revision of Dutch standard for user instructions (NEN 5509) As part of Manualise, over th

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  • 14 July 2015

    Machinery Directive 2006/42/EC

    Which requirements does Machinery Directive have for my operating instructions? Every mac

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  • 21 March 2015

    Madcap Flare 11

    10 Reasons Why MadCap's Flare 11 Sets the Standard As a technical communication service b

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CE-marking medical software

CE marking for medical software and medical devices.

When does medical software need a CE certification? Medical devices, such as infusion pumps and MRI scanners, need to be certified according to European CE rules. For a manufact ...

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By: Manualise On: 14 July 2017 Category: Law and legislation
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NEN 5509

Revision of Dutch standard for user instructions (NEN 5509) As part of Manualise, over the past few years I have participated in the standards committee for revision of NEN5509 ...

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By: Manualise On: 21 July 2015 Category: Law and legislationStandards
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Machinery Directive 2006/42/EC

Which requirements does Machinery Directive have for my operating instructions? Every machine that is marketed or used within the European Union must comply with the health and ...

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By: Manualise On: 14 July 2015 Category: Law and legislation
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The intended use

Please read the manual

The basis for a safe and healthy use You can read it in almost every manual: a description of the intended use of the product or the machine. It is a description that every tech ...

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By: Manualise On: 20 January 2015 Category: Law and legislation
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Product safety and instructions in the EU and US

Product Safety

The US and EU regulations on instructions for use: A world of difference? Manualise and Michael Gerrits, LL.M In the European Union a manufacturer can use European Harmonized ...

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By: Manualise On: 29 April 2016 Category: Law and legislation
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New radio equipment directive

Wi-Fi homeplug

New DIRECTIVE FOR RADIO EQUIPMENT (2014/53/EC) about the instructions The new directive for radio equipment ( 2014/53/EC)  repeals R&TTE directive (1999/5/EC). The new direc ...

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By: Manualise On: 23 June 2014 Category: Law and legislation
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Colour blindness

Colour Blindness   This week I got in contact with Meinard Noothoven van Goor M.Sc. Van Goor is director of Blind Color. It is Blind Color's mission to stop the unnecess ...

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By: Manualise On: 08 February 2014 Category: Law and legislationUsability
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American standards regarding instructions for use

UL_logo

How do I comply my manual with American standards? To provide CE marking, a manufacturer can use European (harmonised) standards to comply with the CE-directives. When exporti ...

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By: Manualise On: 26 January 2014 Category: Law and legislation
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CE marking

CE-marking's impact upon user manuals The European “New Approach” Directives are the basis for CE (Conformité Européenne) marking. According to these directives, products must ...

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By: Manualise On: 03 January 2014 Category: Law and legislation
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