Elsmar Cove Quality DiscussionsRevised MDSAP Audit Model - Health Canada - October 30, 2017The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
Revised MDSAP Audit Model - Health Canada - October 30, 2017
UL - Underwriters Laboratories - Health Sciences
Revised MDSAP Audit Model - Health Canada - October 30, 2017
Revised MDSAP Audit Model - Health Canada - October 30, 2017
Revised MDSAP Audit Model - Health Canada - October 30, 2017
Revised MDSAP Audit Model - Health Canada - October 30, 2017
Revised MDSAP Audit Model - Health Canada - October 30, 2017
Revised MDSAP Audit Model - Health Canada - October 30, 2017
Revised MDSAP Audit Model - Health Canada - October 30, 2017
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Revised MDSAP Audit Model - Health Canada - October 30, 2017


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
2017, health canada, mdsap (medical device single audit program)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 21st November 2017, 10:36 AM
jiligan

 
 
Total Posts: 12
Question Revised MDSAP Audit Model - Health Canada - October 30, 2017

Health Canada sent a notice on October 30, 2017, stating:

[I]Health Canada has received comments from Canadian medical device licence holders regarding the current audit-time model for MDSAP and subsequent annual surveillance audits. To address these comments, the MDSAP Consortium has implemented the following changes:

Streamlined the MDSAP audit approach in the revised version of the audit model.

Does anyone know where I might find this "Revised" Audit Model that they are referring to?

Thanks!
Thanks to jiligan for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 21st November 2017, 12:12 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,133
Re: Revised MDSAP Audit Model - Health Canada - October 30, 2017

The MDSAP Audit Model documents and associated command media are available @ this link.
  Post Number #3  
Old 21st November 2017, 12:17 PM
jiligan

 
 
Total Posts: 12
Re: Revised MDSAP Audit Model - Health Canada - October 30, 2017

Thank you Sidney Vianna for the link to the Audit Companion and Model. I realize the Companion was revised in April 2017 and the link reflects that revision, however I believe there may be a revision to the Audit Model that is not on the FDA site. Could it be that it is newly released and not been added to the FDA site?
  Post Number #4  
Old 21st November 2017, 12:34 PM
Edward Reesor

 
 
Total Posts: 58
Re: Revised MDSAP Audit Model - Health Canada - October 30, 2017

The announcement itself wasn't very informative because of the very issue you stated above. As a small company, I should expect a 20% reduction, but then all manufacturers will receive a 20% reduction, so am I to expect a 40% reduction in audit time?

I just sent a request for detailed information to Health Canada from their website (on the announcement page contact - qs_mdb_hc@hc-sc.gc.ca) and will forward any response I receive.
Thanks to Edward Reesor for your informative Post and/or Attachment!
  Post Number #5  
Old 21st November 2017, 12:37 PM
jiligan

 
 
Total Posts: 12
Re: Revised MDSAP Audit Model - Health Canada - October 30, 2017

Edward Reesor thank you! Any information that you can share on this subject would be greatly appreciated.
  Post Number #6  
Old 21st November 2017, 12:55 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,133
Re: Revised MDSAP Audit Model - Health Canada - October 30, 2017

Quote:
In Reply to Parent Post by jiligan View Post

Could it be that it is newly released and not been added to the FDA site?
I am not an expert on this, but, from what I gathered, the "changes" are related basically to the minimum audit time, what was captured in the Audit Time Determination Procedure which is dated 2017-08-31.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #7  
Old 21st November 2017, 02:36 PM
jiligan

 
 
Total Posts: 12
Re: Revised MDSAP Audit Model - Health Canada - October 30, 2017

Thank you Sidney Vianna!
  Post Number #8  
Old 21st November 2017, 03:45 PM
mihzago

 
 
Total Posts: 176
Re: Revised MDSAP Audit Model - Health Canada - October 30, 2017

Sidney provided a link to a document that is the source of the change mentioned in the notification from Health Canada.
If you notice, the updated Procedure in section 5.3.6 allows for reduction in time up to 20%, but not for everyone, only for companies with less than 15 people; or 10% for companies with 15-45 people.
Thank You to mihzago for your informative Post and/or Attachment!
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
MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US jiligan ISO 13485:2016 - Medical Device Quality Management Systems 3 25th August 2017 07:54 AM
IAQG Cleveland, Ohio Meeting - October 16-19, 2017 Marc AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0 1st July 2017 02:24 PM
Mandatory Problem Reporting Forms for Health Canada (Canada's SOR 98-282) Susan07 Other Medical Device Regulations World-Wide 6 22nd March 2013 09:24 AM
Sell Class III medical devices to Canada prior to Health Canada Approval luloo117117 ISO 13485:2016 - Medical Device Quality Management Systems 11 19th August 2009 06:53 AM
Verband der Automobilindustrie e.V. - VDA 2 has been Revised - October 2003 Hermann - 2011 VDA Standards - Germany's Automotive Standards 3 19th April 2005 11:58 AM



The time now is 08:17 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"