Technical Documentation
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 documents 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.
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, quality management system 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.
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If you have any questions or need help, feel free to contact with our team.
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Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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0044 7719761764
0044 2080667260 - Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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- Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE