Technical File for CE Mark declaration - Template or Sample of required contents

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BRIAN777

Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?
 

Al Rosen

Leader
Super Moderator
Re: Technical File for CE declaration - Template or Sample of required contents

I've posted that previously. Have you searched the forums and the post attachments?
 
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BRIAN777

Re: Technical File for CE declaration - Template or Sample of required contents

I search for the information as Al indicated but was unsuccessful.

Thank you Mr. cforcier for the link. It's such a great resource.

I've come to appreciate this web site.
 
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cjbritt524

Re: Technical File for CE declaration - Template or Sample of required contents

Table Of Contents

Section 1. General Description Of Device
Section 2. Variants
Section 3. Design Drawings And Diagrams Of Components, Sub-assemblies, Etc.
Section 4. Methods Of Manufacture
Section 5. Methods Of Sterilization And Validation
Section 6. Descriptions And Explanations Of Design Drawings, Diagrams, And Operation Of Product
Section 7. Essential Requirements
Section 8. Applicable Standards
Section 9. Hazards Analysis
Section 10. Results Of Design Calculations And Inspections
Section 11. Connection To Other Devices
Section 12. Incorporation Of Medicinal Substances
Section 13. Clinical Information
Section 14. Instructions For Use
Section 15. Previous Regulatory Clearances
Section 16. Product Accessories And Instruments
Section 17. Declaration Of Conformity
 
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BRIAN777

Re: Technical File for CE declaration - Template or Sample of required contents

Thank you everyone for your postings. I now have valuable resources I can use use put together our TF.
 
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ddaniel

Re: Technical File for CE declaration - Template or Sample of required contents

thank you for your help. I find it usefull.
 
D

ddaniel

Re: Technical File for CE declaration - Template or Sample of required contents

thank you. i find it usefull
 
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