Technical file / STED

Do you plan to develop a medical device and you want to obtain the CE marking quickly?

Obtaining the CE marking is not always easy because of the multitude of information requested. You must establish a technical file, but how can you be sure that the file is complete and complies with the regulatory requirements assessed by notified bodies? You cannot manage to have updated technical documentation during your audit?

Nex’file is more than just proof of compliance; it allows you to have in your organisation:

  • A strategic business tool;
  • A fundamental tool for monitoring and control products;
  • A planning tool;
  • Shared responsibilities;
  • Separate departments involved;
  • Parts drafted by real experts;
  • Simplified monitoring;
  • A simple, efficient and reproducible method for all the company’s products. 

Since 2007, Nex’file has been developed on the basis of the technical file in the STED format. This format will be made mandatory in the future European regulation and it is also recommended or mandatory in many countries.

Nexialist offers several support solutions, depending on your needs and your market opportunities.

Business cases

Case 1

Demonstrating regulatory compliance