RISK ANALYSIS

The risk analysis is the fundamental document contained in the technical file and is essential to design a product, regardless of whether or not it is CE marked.

Performing the risk analysis is the first fundamental step in design to immediately eliminate or reduce risks.

If it is not possible to completely eliminate a risk (residual risk), the precautions and countermeasures that operators must adopt to guarantee their safety in the use of the product must be foreseen so information must be reported in the instruction manual as “residual risks” of the product itself.

In the planning phase, routine and extreme preparation of designers can sometimes make certain aspects obvious and this translates into a risk analysis that is not very objective and consequently lacking. For this reason it is good to entrust this task to a trained technician, better if outside the company organization.
Only after completing the risk analysis is it possible to proceed with the preparation of the instruction manual.

A common mistake is to start with the manual and then carry out the risk analysis and establish the technical file.

CEAdvice guides you to prepare the correct documentation to be in compliance with the European laws related to your product and provides you with all the assistance to meet the obligations required, allowing you to legally put your product into free circulation on the European market. CEAdvice give you the know-how to implement and independently manage the process, which is mandatory by law throughout the European Community.