Studio tau – Technical file consultancy

There are rules, varying according to the geographical area, to place a product on a market. These rules require that the company constitutes a technical product file to verify its compliance with the current requirements.

This involves a set of activities, that require for both technical, regulatory and procedural expertise. 

It is necessary to prepare a documentation including:

– Identification of the manufacturer (or of the subject which introduces the product on the market) and of the product

– Risk analysis document and description of the related solutions

– Technical documentation including software

– Manufacturing indications, verification and test procedures

– User’s manual, including  installation and maintenance instructions as applicable.

This documentation must be kept available to the competent Authorities for audit purposes.

The availability of a suitable Technical File is the best guarantee for the manufacturer to successfully deal with any possible civil liability issues from the product. 

In Europe this activity is a precondition for correctly affixing CE marking, necessary  to place the product on the market.

Generally speaking, similar requirements apply in all the different markets, with difference more in the format than in the substance; where needed it can be used also for Product certification.

Studio tau offers technical file consultancy for the products falling within the scope of principal European Directives and Regulations and the current regulatory provisions in force in the major markets of interest.