Product technical file example

In addition, Certification Experts swiftly came up with solutions for obstacles we encountered during the certification process. After reviewing our documentation, they gave us structured feedback and showed us a way forward to compliance with EU directives. We were impressed with their good technical understanding and detailed feedback to our complex test solution in a short timeframe.

With good teamwork and on-site field service we got the CSA certification for our testers. With offices in the US, the Netherlands, Germany and China we offer tailored solutions for all complexities our clients encounter. We dedicate our services to improve the safety level for products of our clients and subsequently for a safer world for everyone.

We only send you relevant news and you can unsubscribe at any time. Your data safety is important to us. Home A detailed look into technical files. Call us. A detailed look into technical files. An important part of the CE marking process is compiling the documentation that proves that your product is safe to use.

Elize van der Laan 5 min read. The Technical File TF or Technical Documentation is a set of documents that contains all of the relevant information of a specific product, including information about its: Design Function Instructions Tests Safety The main purpose of the Technical File is to demonstrate that a product complies with the applicable EU Directive s for health and safety.

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Transitional Periods. Contact Us. Johner-Institute Regulatory Affairs And more Technical Documentation. Technical Documentation for Medical Devices The term technical documentation or technical file refers to all the documents that a medical device manufacturer must submit.

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Can be created and published by the manufacturers in order to help consumers and potential clients choose products or helping them how to use the products. Specifies characteristics in a precise structure, this will help authorize the information needed to be processed in a certain product. Can facilitate information that is for display, design, testing, interfacing, and verification of a product. When it comes to product sheet making, you have a very small margin for error.

As your business relies on your products, you need reliable documents to keep track of them and make sure that they are doing better than expected in the market.