Getting Started

Thanks to this knowledge base:

• You will know how to find out which directives are related to which types of products regulated in the EU

• You know how to identify the EU requirements for user manuals

• You will know which standards to use for creating user instructions

• You will know how to write warnings, precautions for use and safety information

• You will identify legislation (laws/directives) and standards

• You will identify requirements of the legislation and standards that apply to your product

• You will add legal content to the instruction manual

   

  Remember: The user manual is part of the product. It therefore requires the same attention and quality criteria as the product itself thus it is a particularly important tool for fulfilling the instruction responsibility. Only a contextually correct and complete user manual permits exculpatory evidence.

   

  Be familiar with ISO 9001: