The Cove Business Standards Discussion Forums
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
UL - Underwriters Laboratories - Health Sciences
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4 - Page 2


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


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


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

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


Some Related Topic Tags
equivalent medical devices, mdr (medical device regulations), meddev - ec guidelines on medical devices, user group
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 28th May 2018, 09:27 AM
FoGia

 
 
Total Posts: 40
Re: CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4

There is indeed confusion regarding this table. Nowhere is it stated in the MDD that you can't rely on equivalency after your device has been CE-marked. The table assumes that after CE-marking you have gathered sufficient data on your own. Still, as long as you claim equivalency to leverage the data from another device you have to demonstrate it in every CER (according to the rule that a CER should be a standalone document)?
Thanks to FoGia for your informative Post and/or Attachment!

Sponsored Links
  Post Number #10  
Old 28th May 2018, 10:19 PM
ksuresh

 
 
Total Posts: 7
Re: CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4

Thankyou FoGia
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >

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
Emoticons 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
MEDDEV equivalent requirement to CFR 806.20 Chuck in QA EU Medical Device Regulations 2 16th June 2015 05:07 AM
EU publishes revised guidance on Medical Devices Vigilance system MEDDEV 2.12-1 Rev7 bio_subbu EU Medical Device Regulations 8 13th September 2013 12:21 PM
Acceptance Criteria for Scratches on Medical Devices sreeranjini ISO 13485:2016 - Medical Device Quality Management Systems 3 23rd August 2012 06:04 AM
European Medical Devices Classification ?MEDDEV 2. 4/1 Rev. 9 June 2010? bio_subbu ISO 13485:2016 - Medical Device Quality Management Systems 5 7th August 2010 11:01 AM
Design Input - Question on Specific Performance Criteria for Medical Devices Device Geek Design and Development of Products and Processes 3 16th April 2008 01:06 PM



The time now is 07:22 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"