Law and legislation & Conformity
“Don’t put a cat in the microwave.” Our articles guide you through the complex landscape of legal requirements.
Drafting a Declaration of Conformity
What is a declaration of conformity, why is preparing one so important, how do you do it, and what should you consider? Find the answers to these and more: Manualise helps.
Risk Assessment
What is a risk assessment, why is it important, and which steps does the process involve? And how do you ensure practical and clear safety instructions to address the identified residual risks? Find the answers to these and more: Manualise helps.
Product Liability Act
What exactly does product liability law involve, when is a product considered defective, and what role does the manual play in this? You will find clear practical examples, insight into the requirements for a good manual, and concrete advice to help prevent liability. This ensures you understand how to comply with product liability law and safeguard user safety.
Product Safety USA
Product safety and instructions in the USA: the role of the manual. Similarities and differences compared to the EU. Manualise helps you get started.
Read moreCE marking
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 moreCE-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.
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