Technical Dossier for CE Mark

Technical Dossier for CE Mark

Preparing a Technical Dossier for a product to get a CE mark is not an art that requires a special artistry. Thanks to harmonizing standards in EU, every detail that a Technical File should carry is the same for all manufacturers in any country. 

On the other hand, building a solid Technical File is a time-consuming process. Preparing a scientific, traceable and sustainable Technical File requires a deep experience; in order not to face with non-compliance issues in the future, that creates an additional burden in terms of time, workforce and money.

AdviQual has accomplished many Technical Dossiers in a year, for a wide range of products, for different manufacturers in many countries such as Germany, Egypt, Italy, Kuwait, Ireland, and Turkey.

Wherever your company is located, with the help of the internet providing services remotely is not a barrier anymore. 

Having written dozens of Technical Files in a year brings us quite a deep expertise. Each part of the file is prepared by a different team of consultants, who know the pitfalls who knows the criteria for safe medical devices. Our experts will also recommend safe designof your medical device if they have encountered any deviations from the available and applicable standards and scientific literatures.

We build the Technical File in 7 parts;

  1. Device Description
  2. Labeling / Instruction for Use
  3. Essential Requirements Control
  4. Risk Management
  5. Design and Production Information
  6. Product Verification and Validation (Performance tests, Biocompatibility, Process Validations, etc.)
  7. Post Market Surveillance and Supplier Management

Before final version, we send the draft file to you for any adjustment you may ask and after your approval, we share the final version of the Technical File.

Documents of the Technical File need constant care in parallel with the lifecycle of the Medical Device.

Each change in your production process and technology, any improvements that may affect your product safety and performance requires taking actions and amendments in the related documentation. 

Whenever you don't have enough time or human resources to do these reviews and changes in your hectic daily routine, we can review your current technical file, make the necessary updates and improve the technical file by correcting the deficiencies with you.

We also give consultancy for changing state-of-art of your device or regulations.

 

Please click here to get a quotation about the Technical File. After filling out the form please send us an e-mail info@adviqual.com.

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Technical Dossier for CE Mark