Preparation of technical documentation package in order to present it in the body of compliance estimation.

The manufacturer faces with the necessity of conforming to technical documentation (Technical file) within the scope of the procedure of estimation of medical product compliance to the Technical regulations.

Technical documentation package shall contain the necessary data set by the terms and requirements for the designing processes, manufacture and further operation of the product.

The requirements to technical documentation depend on the type and purpose of products that are objects to compliance estimation.

The company 8L GROUP will render you full qualified maintenance of preparation of technical documentation before its presentation to the body on compliance estimation.
All procedures mentioned above and other accompanying, if necessary.

Please, contact us and we’ll help you to save time and budgets for new opportunities.