Certification Documentation

Sample CE Technical File for Product CE Mark Certification

D108 :
CE Mark Documents


CE Technical File contains more than 45 editable MS-Word files. These editable documents address all the elements of CE mark certification

Content of Sample CE Technical File for Product CE Mark Certification

The contents of the CE - Conformity to European Mark document kit which we offer includes more than 45 document files as listed below:

  1. Sample CE technical file (helpful for Machine, Pressure, EMC, LVD, Medical device and other industry)
  2. Product descriptions, sample process details, product validation reports,
  3. Procedures
  4. sample forms and records.

Note: The sample ce technical file provided by us is a sample and company needs to make own technical file after considering own system as well as applicable directives and product and necessary samples are given in the CE technical file for CE certification.

Index of CE Technical File

  1. Title of each chapter
  2. Scope of Products under CE Certifications
  3. Company Profile
  4. Quality Control and Manufacturing Facilities
  5. Manufacturing Flow chart
  6. Product Descriptions -Technical Specification
  7. Bill of materials
  8. Product Drawings
  9. Product Test Reports
  10. Product Validation Records
  11. Procedure for controlled environment conduct (with contamination control
  12. Procedure for facility maintenance
  13. Procedure for equipment operations and maintenance
  14. Procedure for batch records
  15. Procedure for Identification and Traceability
  16. Process for Handling, storages Packaging, Preservation and Delivery
  17. Procedure for final product release
  18. Procedure for receiving inspection
  19. Process for deviation
  20. Procedure for retain samples
  21. Procedure for stability studies
  22. Process for product recall
  23. Procedure for post market surveillance
  24. Process for Validation
  25. Procedure for labeling
  26. Procedure for CE Marking
  27. Procedure for risk analysis
  28. Procedure for Failure mode effective control analysis
  29. Procedure for product classification and conformity root (Only sterile products)
  30. Procedure of Handling of Non-conformities
  31. Risk analysis
  32. Materials specifications for various products
  33. Quality Plan
  34. Cleaning validation (Plan & Report)
  35. Sealing validation (Plan & Report)
  36. ETO validation (Plan & Report)
  37. Packaging qualification (Plan & Report)
  38. Reports of bio burden
  39. Reports of sterility. Acute toxicity and pyrogen
  40. Test reports from external laboratories
  41. Product applications
  42. Products labels
  43. Use instructions
  44. Declaration of conformity
  45. List of Harmonized Standards
  46. Essential safety requirements

Our sample product technical file for CE Mark can be used for preparation of technical file for any kind of industry after providing necessary details of your company and your products and necessary changes done with the guidelines given in this model technical file.

  • The sample ce technical file documents are in plain English and easy to edit.
  • A soft-copy of an editable document kit is provided, so user can edit it and it covers total documentation package to prepare product technical file.
  • It has been developed by experienced experts.
  • User-friendly and easy to learn in USA, UK, Singapore, Malaysia, Vietnam, South Africa and other countries for establishing good CE technical file for product certification.
How useful?
  • The user can very easily modify the templates according to their products and create the documents for their organization within 7 days.
  • The sample CE technical file enables you to change the contents as per your need. The user can modify the documents as per their industry as well as product and create own technical file for their organization
  • Readymade templates and sample ce technical file documents are available which can reduce your time in document preparation.
  • Saves much time and cost in document preparation in USA and globally
  • In preparation of document kits; it is been verified by our team and more than 10000 hours are spent in preparation of various document kit.
Other Details

Information on CE Technical File - documents for CE Mark certification is covered in CE Mark total documentation package, provided with free DEMO by Global Manager Group. The CE marking is a European proof of conformity and is also described as "passport" that allows manufacturers and exporters to enter products freely within the EU. Many clients are already achieved CE Mark for their products using our document kit and sample CE Mark technical file. The user can modify the templates as per their products and create CE - Mark documents for their organization based on European Union requirements. The Sample CE Technical File is helpful for Machine, Pressure, EMC, LVD, Medical device and other applicable industry products. Our sample ce technical file packages are competitively priced and effectively meet the global customer needs for product certification. The letters, "CE" -- French for "Conformity Europeans," indicate that the manufacturer has satisfied all assessment procedures specified by law for its product.

Global Manager Group has globally reputed team of consultants having rich experience in preparation of sample technical file for CE certification. The user can modify the templates as per their company working system and create their own ce technical file for their product much faster and total documents are in word and easily editable.

Method of Delivery of Sample CE Mark technical file documentation kit

After successfully purchase of our document kit - sample ce technical file, we will provide username and password for online e delivery of our products by ftp download from our server with in 12 to 24 hours.

This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.

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