Medical Devices and IVDs

Technical Documentation

Technical file writing and translations are essential for ensuring the proper functioning, understanding, and safety of products and services across different languages and cultures. Technical file writing involves creating clear, concise, and accurate documents explaining the operation, maintenance, and troubleshooting of technical equipment, software, or processes.

Common types of medical device technical documentation include user manuals, installation guides, service manuals, safety data sheets, white papers, and online help files. Technical translations aim to accurately and culturally sensitively translate technical documents into another language, preserving the intended meaning and function.

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Europe CE Technical File

The Europe CE Technical File, also known as the Technical Documentation, is a crucial component for affixing the CE marking to products on the European market.

It demonstrates conformity with EU directives for specific product categories, justifies the EU Declaration of Conformity, and enables the CE marking, signifying product safety and free movement within the European Economic Area (EEA).

It is required by manufacturers and authorized representatives, and typically includes manufacturer information, product description, design and manufacturing processes, test reports, QMS documentation, technical drawings, user manuals, and the EU Declaration of Conformity.

US FDA Technical File

Manufacturers and sponsors need to submit various types of applications to the FDA for marketing approval of their devices, depending on the risk classification and novelty of the technology. Common types include Premarket Notification (510(k)), Premarket Approval (PMA), Investigational Device Exemption (IDE), De Novo Classification, Q-Submission, and Breakthrough Designation.