Elsmar Cove Quality DiscussionsNew GHTF guidance document on Clinical Studies Performance for IVDsThe Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
New GHTF guidance document on Clinical Studies Performance for IVDs
UL - Underwriters Laboratories - Health Sciences
New GHTF guidance document on Clinical Studies Performance for IVDs
New GHTF guidance document on Clinical Studies Performance for IVDs
New GHTF guidance document on Clinical Studies Performance for IVDs
New GHTF guidance document on Clinical Studies Performance for IVDs
New GHTF guidance document on Clinical Studies Performance for IVDs
New GHTF guidance document on Clinical Studies Performance for IVDs
New GHTF guidance document on Clinical Studies Performance for IVDs
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

New GHTF guidance document on Clinical Studies Performance for IVDs


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

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

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
ghtf (global harmonization task force), clinical trials and studies and investigations, ivd (in vitro diagnostic) devices and reagens
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 2nd February 2012, 10:55 PM
sreenu927

 
 
Total Posts: 538
Look! New GHTF guidance document on Clinical Studies Performance for IVDs

Hi All,

There is a new guidance document from GHTF on "Clinical Studies Performance for IVD medical devices."

Regards,
Sreenu
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf SG5_N8R3_Clinical Performance Studies for IVD Medical Devices_GHTF Guidance.pdf (246.4 KB, 69 views)
Thank You to sreenu927 for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 25th March 2012, 08:09 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,171
Re: New GHTF guidance document on Clinical Studies Performance for IVDs

Quote:
In Reply to Parent Post by sreenu927 View Post

Hi All,

There is a new guidance document from GHTF on "Clinical Studies Performance for IVD medical devices."

Regards,
Sreenu
Its strange that GHTF is issuing out guidance documents esp. when it is commented that the GHTF organization will no longer remain.
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
FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies rangani_rj Other US Medical Device Regulations 3 17th September 2014 07:21 AM
Final FDA Guidance on IDEs for Early Feasibility Clinical Studies - 2013 sreenu927 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0 10th October 2013 07:57 PM
GHTF Issues Draft Guidance Document on UDI System for Medical Devices bio_subbu Other Medical Device Related Standards 1 28th November 2010 02:40 AM
USFDA issues Final Guidance Document on InVitro Diagnostic Device (IVD) Studies bio_subbu 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1 29th June 2010 09:02 AM
FDA released guidance on use of Bayesian statistics in Clinical Studies bio_subbu 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0 7th February 2010 11:46 AM



The time now is 05:35 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"