The European “New Approach” Directives are the basis for CE (Conformité Européenne) marking. According to these directives, products must meet certain requirements before being sold in the EU, with manuals playing a vital role in the regulatory process. In order to ensure that your product is able to be widely distributed within the EU, it’s important to know what the European New Approach Directives mean, and exactly how they will impact you and the manuals of the products that you offer.Read more
Writing an instruction manual
Writing an instruction manual is a serious business. More often than not, the first experience for a customer is not with the product itself, but with its instruction manual. In order to to make a customer journey as pleasant as possible, the instruction manual should be an integral part of any product experience. This implies that any company selling hardware or software, should plan the production of an instruction manual as early as possible. This is the best guarantee that the manual will be up to standard. What ‘up to standard’ means, should become clear in this article.Read more
How to write a technical manual
What is technical manual writing? This all boils down to the question: what is a technical manual? ‘Technical manual’ is a term for any manual with a technical character. You could think of a manual (or set of manuals) for a complicated machine like an airplane. You could also think of technical manuals to run a complete industrial installation.Read more
CE-marking medical software
Medical devices, such as infusion pumps and MRI scanners, need to be certified according to European CE rules. For a manufacturer, however, it is not always clear whether his product needs a ‘medical’ CE certification. This is especially true for any embedded software.Read more
User documentation: what is the best choice?
User documentation’ is a very general term indeed. What does it mean? Actually, it means quite a lot. And here lies the problem. If the choice for the right mix of user documentation is so overwhelming, how does one make the right choice? This is up for discussion. At any rate, it is important to keep any door open to any form of user documentation. First, there are the user documentation types. Second, there are the output channels for these documentation types. Let’s start with the user documentation types.Read more
What are good product instructions?
Good product instructions are worth every penny and more than that. How come? One just has to think of the reduction in costs for any helpdesk if product instructions are both complete and understandable. Although opinions differ, the reduction in costs for a helpdesk could be close to 60%. How to write good product instructions?Read more
What are mandatory instructions?
Do mandatory instructions exist, whether these would be mandatory online instructions, mandatory operating instructions or any other kind of working instructions? Actually, they do not. There is nothing ‘mandatory’ about instructions. The term ‘mandatory instruction’ has its merits though. One could interpret mandatory instructions as instructions that should meet certain criteria.Read more
How to Create a Technical File When Importing from China
Ensuring compliance with EU regulations, including the creation of a technical file, is complicated enough as it is. Throw a supplier on the other side of the plan, that may not even know what a ‘Declaration of Conformity’’ is, and you have a real problem to deal with. In this article, Fredrik Gronkvist, co-founder of Chinaimportal.com, explains what European importers must know about ensuring compliance with various CE marking directives and creating technical files, when buying products from Chinese manufacturers.Read more
In the design phase of a user manual, it is important to know whether the interactions with the user are optimal. The best answer to this question can be obtained by conducting a user research.Read more
European directives and… manuals
Almost all countries in Europe are member of the European Union, or are somehow affiliated to the EU. This has important consequences for setting up any manual. In the EU, the European directives on the safe use of a product also have something to say on the requirements for the accompanying manual. As such, a company can be held accountable if a manual is not in compliance with the relevant European directive.Read more