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Global Consultancy & training company for system implementation, certification documentation, awarness & auditor training and management training consultancy. We offer QMS, EMS, FSMS, ISMS, ITSMS, EnMS, CMM, Laboratory Accrediation, CE MARK crtification solution with readymade referance Documentation and Training presentation kits in India, USA, UK, Europe UAE, Bahrain, Qatar, Australia etc. more than 65 countries.
 
 Certification Documentation

D108 : CE mark sample technical file for CE mark certification

399.00 USD Demo

Information on CE Mark documents for quick CE Mark certification with complete list of total documentation package is provided in 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 circulate products freely within the EU. Many clients are already certified 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 (EU) standard. The sample CE Technical File is helpful for Machine, Pressure, EMC, LVD, Medical device and other directives as well as preparation of ce software. Our sample CE Technical file packages are competitively priced and effectively meet the global customer needs for CE Mark product certification. The letters, "CE" -- French for "Conformity Europeans," indicate that the manufacturer has satisfied all assessment procedures specified by law for its product. Our consulting team has prepared documents conforming to the requirements of CE Mark standard and globally many clients from USA, UK, Middle East, Europe, Asia are already using our documents and ready to use templates and already certified.

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

 

Content of CE Mark technical file consists of the following:

The contents of the document kit which we offer includes more than 45 document files as listed below:

  • CE technical sample file (helpful for Machine, Pressure, EMC, LVD, Medical device and other CE directives for CE Mark)
  • Product descriptions, sample process details, product validation reports,
  • CE Procedures
  • CE 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 CE technical file 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 is helpful for Machine, Pressure, EMC, LVD, Medical device and other directives.

All the CE Mark standard documents provided are editable and the user can easily modify the name of the company, its logo and other things required by your company.

  Features
  • CE Mark documents are in plain English and easy to edit.
  • A soft-copy of an editable CE Mark document kit is provided, so user can edit it and it covers total documentation package.
  • It has been developed by experienced experts.
  • The entire CE sample technical file is prepared by our experienced team in implementing the CE certification in different types of companies with the help of medical, machine or electrical directives and having rich experience for the establishment of the best CE technical file preparation.
  • User-friendly and easy to learn in USA, UK, Singapore, Malaysia, Vietnam, South Africa and other countries for establishing good CE Mark standard.
 

How CE Mark Certification Documents are Useful to You?

  • The user can very easily modify the templates according to their products and create the CE documents for their organization within 3 days.
  • 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 CE technical file for their organization based on CE directives
  • Readymade templates and sample documents are available which can reduce your time in CE document preparation.
  • Saves much time and cost in document preparation in USA and other countries globally
  • Save much time and cost in document preparation
  • Our products are highly sold globally and used by many multinational companies and had provided total customer satisfaction as well as value for money,
  • 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

Method of Delivery of CE Mark Documentation Kit

After successfully purchase of our document kit, 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. The content of this CE Mark editable package includes:

  • CE Technical sample file
  • Product descriptions, sample process details, product validation reports
  • CE Procedures
  • CE sample forms and records
This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.

For more details on System Certification, Contact Us or to see demo of our products, visit our E-Shop.
 
D108 : CE mark sample technical file for CE mark certification 399.00 USD Demo
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