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- Welcome to P&C CORP
- p&ccomp@gmail.com
A Technical File (TF) contains relevant information demonstrating that your product complies with the essential requirements as outlined in the relevant directives and regulations. It is a mandatory component of proving the conformity of your product. As your full-service compliance partner, Certification Experts can assist you in gathering all necessary information and compiling the Technical File or Technical Documentation. With over 25 years of experience, you can trust us to demonstrate the conformity of your product, enabling you to market it in the desired market.
The terms “Technical File” and “Technical Documentation” are used in the context of regulatory compliance, particularly in fields like product certification and CE marking. The term “Technical Documentation” is used within the newer directives and regulation. What was previously called the Technical Construction File and is now primarily referred to simply as the Technical File or Technical Documentation is essentially a compilation of all relevant information demonstrating compliance with the essential requirements of the applicable directives and/or regulations during the production of your product. This includes all documents and calculations used to design and build the product. The Technical File must remain available to the competent authorities of the member states for at least ten years from the construction date of the product (such as machine, toys, medical device) or, in the case of serial production, from the date of production of the last product. For the manufacturer, their Authorised Representative, or the importer, the Technical Documentation also serves as technical evidence that may provide defense possibilities in liability claims. One should be cautious with compiling a Technical File, as it varies by product group. Examples of products for which Technical Files take different forms include:
Technical file for Machinery Directive
Technical file for electricity
Technical file for medical devices
Technical file for CE
The content of the Technical File is determined in accordance with the respective products for each directive and regulation.
Despite the variations within the content of the Technical File and content of the technical construction files for the different product groups, there is a general list of documents that essentially form a Technical File Checklist. This includes:
A general description of the product
Risk Assessment to determine applicable safety and health requirements for the product
Design and manufacturing drawings
Detailed technical data on essential aspects of the product
A list of standards and essential requirements complied with
Documentation of performed calculations and tests
If applicable, certificates and inspection reports
User information, including manuals, labeling, and packaging.
If applicable, internal provisions adhered to ensure compliance with the directives and/or regulations
P&C is committed to ensuring product quality through the investment in advanced inspection systems such as AOI, ICT, and automated functional testing lines.
Every product is strictly monitored at each stage to meet all technical specifications and customer requirements.
We rigorously apply international quality management standards such as ISO 9001, aiming for a “zero defect” target and complete customer satisfaction in every project.
