The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > EU Medical Device Regulations
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

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


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links



Courtesy Quick Links

Links that Cove visitors will find useful in your quest for knowledge:


ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Atul's
Quality Forum Online

Howard's
International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Related LinkedIn Groups

ISO 9001 for Small Businesses

ISO 9001:2015 Revision Discussions

Information Security Community

Medical Devices Group

Quality and Regulatory Network

FDA (Food and Drugs)

AS91XX Series - Tips and Advice


Related Topic Tags
technical file, template, ce mark and ce marking, technical files for medical devices, contents (general term), forms and templates (general)
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 5 votes, 4.40 average. Display Modes
  Post Number #1  
Old 4th January 2007, 08:00 PM
BRIAN777

 
 
Total Posts: 7
Thank You! Technical File for CE Mark declaration - Template or Sample of required contents

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

Sponsored Links
  Post Number #2  
Old 5th January 2007, 09:45 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,542
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?
Sponsored Links

  Post Number #3  
Old 10th January 2007, 04:26 PM
cforcier

 
 
Total Posts: 2
Re: Technical File for CE declaration - Template or Sample of required contents

There is a free guidance document on the content of technical files (NB-MED/2.5.1/Rec5).

You can find it at http://www.team-nb.org/

Regards,
Thank You to cforcier for your informative Post and/or Attachment!
  Post Number #4  
Old 10th January 2007, 06:31 PM
BRIAN777

 
 
Total Posts: 7
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.
  Post Number #5  
Old 10th January 2007, 07:05 PM
cjbritt524

 
 
Total Posts: 4
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
Thanks to cjbritt524 for your informative Post and/or Attachment!
  Post Number #6  
Old 11th January 2007, 10:32 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,542
Re: Technical File for CE declaration - Template or Sample of required contents

Look at the thread, Technical Files - Please explain differences and what information would be included
Thank You to Al Rosen for your informative Post and/or Attachment!
  Post Number #7  
Old 11th January 2007, 11:35 AM
jkonholm

 
 
Total Posts: 25
Re: Technical File for CE declaration - Template or Sample of required contents

Quote:
In Reply to Parent Post by BRIAN777 View Post

Does anyone have a template or sample of the contents of a technical file to prepare for CE declaration?
see attachment: "Guidance Document Technical Files / Design Dossiers"

Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Non-Active Medical Devices-Products.pdf (134.3 KB, 1976 views)
Thank You to jkonholm for your informative Post and/or Attachment!
  Post Number #8  
Old 11th January 2007, 04:27 PM
BRIAN777

 
 
Total Posts: 7
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.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > EU Medical Device Regulations

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Review of Technical File for CE mark JoCam EU Medical Device Regulations 6 12th May 2016 01:27 AM
CE Mark Technical File - Procedure for the generation of a "Technical File" highlyexpqe ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 5 2nd December 2014 11:34 AM
CE Mark / TCF (Technical Construction File) File sample achih100 EU Medical Device Regulations 10 21st December 2012 04:49 PM
EC Technical File DoC (Declaration of Conformity) Content Requirements Arnthor EU Medical Device Regulations 8 4th May 2011 12:46 PM
Technical File Contents ISO 13485 sundancer ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 5 19th May 2010 03:05 AM



The time now is 03:59 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


NOTE: This forum uses "Cookies" -- The Elsmar Cove is *Copyright Free*.
A Peachfarm LLC Internet Property