TechFile Manager

Introduction to functionality
Gruppo SASI offer for the management of the Technical File for Medical Devices is developed in full compliance with the legislation in force for the European community as illustrated in the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. and repealing Council Directives 90/385/EEC and 93/42/EEC. The definition for the Technical File is provided in Annex II "TECHNICAL DOCUMENTATION" and in the following subparagraphs, in Annex III "TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE" and in Annex IV "EU DECLARATION OF CONFORMITY". The organizational model useful to face the amount of documents that will have to be produced and that will become mandatory from May 2021 needs a computer tool comparable to a document management on the eCTD model in use in the pharmaceutical world.


The Gruppo SASI’s “TechFile Manager” solution for document management aimed at the electronic production of the Technical File has been developed and is based on some important elements such as:
CFR 21 Part 11 and Annex 11 compliance:
The system have the necessary validation capabilities including:


To finish, we want to underline that the system is developed with the collaboration of specialists working in the Medical Devices field and especially in the implementation and subsequent management of the Technical File. Therefore, the result is a constantly careful design to meet the most complex application needs entrusting the system with the correct interpretation of the legislation to allow users to focus exclusively on professional content of their role facilitating and streamlining day-to-day activities impacting on the documentary management of the Technical File and making it easier the consultation for Notified Bodies.