The Cove Business Standards Discussion Forums
MDSAP cost per jurisdiction
UL - Underwriters Laboratories - Health Sciences
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
MDSAP cost per jurisdiction
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

MDSAP cost per jurisdiction - 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
mdsap (medical device single audit program)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 16th May 2018, 11:11 AM
Edward Reesor

 
 
Total Posts: 72
Re: MDSAP cost per jurisdiction

Please note that Health Canada is interested in receiving information on the cost of MDSAP and how it will affect your business in Canada.

Please send your comments, cost estimates and intentions to Health Canada (and forward this message to your colleagues who are in the same situation).

Sponsored Links
  Post Number #10  
Old 16th May 2018, 02:00 PM
Mark Meer

 
 
Total Posts: 780
Re: MDSAP cost per jurisdiction

Quote:
In Reply to Parent Post by Edward Reesor View Post

... Please send your comments, cost estimates and intentions to Health Canada (and forward this message to your colleagues who are in the same situation).
Second this.

However, realistically I don't know what we expect Health Canada to do at this point. I can think of the following (but all have their problems...):

a) further audit-time reductions
- I doubt if they could do this anymore than they have already. Depending on product line & manufacturing processes, small companies apparently are eligible for up to 35% audit-time reduction. It's still a lot more time than ISO/CMDCAS, but even so, this is no longer the bulk of the cost (see point b below).

b) reducing required administrative costs or barriers-to-entry for auditing organizations
- This is where the most gains could be made if possible. Our AO admitted that 1/2 to 2/3 of the quoted cost is just their administrative fees (so audit-time reductions don't affect). Ideally, it'd be easier for AOs to have MDSAP recognition to encourage competition, and lower prices (as AOs don't have huge costs to compensate for).

c) subsidies for small businesses
- Doubtful. But even if, it would only be for Canadian manufacturers.

d) extension of the deadline
- Possible. As the deadline grows nearer, and if there are still many companies not compliant or exiting the market, this may be their only option. Unfortunately, this would effectively punish those companies that diligently arranged to be compliant by the deadline.

e) revoke the mandate altogether
- This would be my ideal outcome....but realistically I don't see it happening.

In anycase, regardless of whether they can do anything at this point or not, DO take Edward Reesor's advice, and contact Health Canada to express your concerns. At the very least, it is good to make them aware of how their policies are challenging/hurting the healthcare market in Canada.
Thanks to Mark Meer for your informative Post and/or Attachment!
  Post Number #11  
Old 17th May 2018, 03:42 AM
nozzle

 
 
Total Posts: 14
Re: MDSAP cost per jurisdiction

Quote:
In Reply to Parent Post by matinino View Post

Dear Nozzle,

Our NB quoted 30k on top of their several thousands for the ISO 13485:2016. And yearly 24k extra after that.
Which is your NB (BSI UK?)

Thanks, Maarten
Hi Maarten,
Our notified body is SGS UK. So far we still haven't received an official quote as the latest update from Health Canada point towards reduced audit time for smaller businesses.
  Post Number #12  
Old 17th May 2018, 09:54 AM
JoshuaFroud

 
 
Total Posts: 5
Re: MDSAP cost per jurisdiction

Hi Nozzle

I work for a small company ~40 people. We have received a quote of ~7k and 12-15 audit days. Which is roughly half what it was prior to the recent revision of audit times.

Hopefully, that is useful.
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
Cost Of PPAP - What is the average cost? Is there a Yearly cost? gpainter APQP and PPAP 8 25th June 2011 11:48 AM
FDA's jurisdiction over Non-Research Medical Clinics - Question Quality96 - 2011 US Food and Drug Administration (FDA) 2 14th March 2011 09:36 AM
FMEA Cost Column added to Associate and Prioritize Risks according to Cost qualityboi FMEA and Control Plans 10 6th March 2008 12:14 PM
Re-Arrangement Cost, Quality Cost, Start-Up Costs, Hourly C&B and Subcontractors tomccchang Manufacturing and Related Processes 6 6th August 2006 09:35 AM
Licensing jurisdiction of the US Department of Commerce tyker Various Other Specifications, Standards, and related Requirements 1 8th May 2006 10:04 AM



The time now is 11:49 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"
The Elsmar Cove web site and all content is owned by Rabbithash Corp. as of 1 MAY 2018.
Unlike Facebook and other properties such as Linkedin, We don't buy, sell, or "share" visitor information. Never have, Never will...
GDPR Compliant since 1996, keeping Marc's vision alive!