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Recent blog items
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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
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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
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 ...
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 ...
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 ...
The intended use
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 ...
Product safety and instructions in the EU and US
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 ...
New radio equipment directive
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 ...
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 ...
American standards regarding instructions for use
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 ...
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 ...