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:
• Sample CE technical file (helpful for Machine, Pressure, EMC, LVD, Medical device and other industry)
• Product descriptions, sample process details, product validation reports,
• Procedures
• sample forms and records.
• Note: The sample CE technical file provided by us is a sample and the company needs to make its own technical file after considering its 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
• Title of each chapter
• Scope of Products under CE Certifications
• Company Profile
• Quality Control and Manufacturing Facilities
• Manufacturing Flow chart
• Product Descriptions -Technical Specification
• Bill of materials
• Product Drawings
• Product Test Reports
• Product Validation Records
• Procedure for controlled environment conduct (with contamination control
• Procedure for facility maintenance
• Procedure for equipment operations and maintenance
• Procedure for batch records
• Procedure for Identification and Traceability
• Process for Handling, storages Packaging, Preservation and Delivery
• Procedure for final product release
• Procedure for receiving an inspection
• Process for deviation
• Procedure for retaining samples
• Procedure for stability studies
• Process for product recall
• Procedure for post-market surveillance
• Process for Validation
• Procedure for labeling
• Procedure for CE Marking
• Procedure for risk analysis
• Procedure for Failure mode effective control analysis
• Procedure for product classification and conformity root (Only sterile products)
• The procedure of Handling of Non-conformities
• Risk analysis
• Materials specifications for various products
• Quality Plan
• Cleaning validation (Plan & Report)
• Sealing validation (Plan & Report)
• ETO validation (Plan & Report)
• Packaging qualification (Plan & Report)
• Reports of bio burden
• Reports of sterility. Acute toxicity and pyrogen
• Test reports from external laboratories
• Product applications
• Products labels
• Use instructions
• Declaration of conformity
• List of Harmonized Standards
• Essential safety requirements
• Our sample product technical file for CE Mark can be used for the 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.
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Features of the Product

• 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 the 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 the USA, UK, Singapore, Malaysia, Vietnam, South Africa and other countries for establishing good CE technical file for product certification.

How This Product is 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 the 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.

PRICE – Rs. 26,500/-

HOW TO BUY

To buy CE MARK Documentation you can call us on +91 96672 69214 or mail us at joinconsultant123@gmail.com