Notice

Medical device TCF Expert

 


 

Medical Device TCF (Technical Construction File)

 

Medical devices are used for diagnostic, treatment, mitigation, and prevention of diseases. Medical device developers must prove to the licensing authority that risk management of products is actually carried out through technical documents about the safety of products and performance. It includes materials, structure, purpose of use, how to use, principles of action, precautions for use, test standards, etc.

 

 

Note - Overview of CE Certification Preparation

  1. Decide on the Standards

    •  Identify the various standards that described the risks associated with the product

    •  Itemize the essential requirements of the relevant guidelines

    •  Document the conformity of the relevant specifications and essential requirements of guidelines.

    •  Documentation the technical responses to protect against risk of use.

     

  2. Conduct of a Test

    •  Attach technical documentation of testing agency as required

    •  Conduct standard tests prescribed in the relevant guidelines

    •  Conduct of Operation test

     

  3. Preparation of Materials

    •  Create of the user manual of the product

    •  Create of the Technical Construction File

    •  Inspect samples as needed

     

  4. Declaration of Conformity

    •  Create a Declaration of Conformity based on the essential requirements in the guidance;

     

  5. CE Marking

    •  Attach Producer name and safety indicator light nameplate according to item

    •  Fabrication and Attachment of CE Marks ​

 

 

Necessity (role) of Medical Device TCF Expert

 

Companies that conduct product certification such as CE Marking, FDA, etc. require technical documentation specialists to organize technical documents and certification bodies to review submitted documents.

 

 

 

Information that configures the Medical Device TCF (Example of CE Marking)

1) PART A: Technical File/Design Dossier

(1) Table of Content

(2) Introduction

(3) Design Dossier/Technical File Summary Information

 

2) PART B: Annexes

  (1) Essential Requirements Checklist

  (2) Risk Analysis

  (3) Drawings, Design -, Product – Specifications 

  (4) Chemical, Physical and Biological Tests 

 

      (4-1) In Vitro Testing - Preclinical Studies 

      (4-2) In Vivo Testing - Preclinical Studies

      (4-3) Biocompatibility Tests 

      (4-4) Bio-stability Tests 

 

  (5) Clinical Data 

  (6) Labels and Instructions for Use 

  (7) Manufacturing

  (8) Package Qualification and Shelf life

  (9) Sterilization 

  (10) Conclusion 

  (11) Declaration of Conformity


   

 

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