The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Other Medical Device and Orthopedic Related Topics
Forum Username

Elsmar Cove Forum Visitor Notice(s)


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access
Courtesy Quick Links

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

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
classification(s) of parts or products
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 12th March 2012, 11:15 AM
kakoni kakoni is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Mar 2012
 
Posts: 5
Thanks Given to Others: 0
Thanked 2 Times in 2 Posts
Karma Power: 9
Karma: 20
kakoni has less than 100 Karma points so far.
Question What constitutes (is defined as) as a Medical Device?

Hi all.

There is this device company called glooko that makes special cable for iphone that can be used to sync data from blood glucose meters into their iphone app.

To me it seems that this system is not classified as medical device(=Understandable, but when reading mdd it seems that this would fell into i/iia category).

So I guess my question goes;
- How are these 3rd party enablers (like in this case communication enabler between iphone and bg meter) seen in the regulatory world?

Sponsored Links
  #2  
Old 12th March 2012, 01:04 PM
somashekar's Avatar
somashekar somashekar is offline
Cross Forum Moderator

 
Registration Date: Mar 2008
Location: Bangalore city, INDIA
 
Posts: 4,365
Thanks Given to Others: 1,413
Thanked 2,266 Times in 1,599 Posts
Blog Entries: 2
Karma Power: 490
Karma: 14577
somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.
somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.
Send a message via Yahoo to somashekar
Re: What constitutes (is defined as) as a Medical Device?

Quote:
In Reply to Parent Post by kakoni View Post

Hi all.

There is this device company called glooko that makes special cable for iphone that can be used to sync data from blood glucose meters into their iphone app.

To me it seems that this system is not classified as medical device(=Understandable, but when reading mdd it seems that this would fell into i/iia category).

So I guess my question goes;
- How are these 3rd party enablers (like in this case communication enabler between iphone and bg meter) seen in the regulatory world?
A device is a medical device if the manufacturer so intends ...
So glooko is making it for the iphone guy or the bg meter guy ?
If the bg meter guy, then its an accessory for his medical device and can so be classified.
So, Mr kakoni, welcome to the cove and tell us if you represent glooko, or the iphone company or the bg meter company.

__________________

Best Regards...
Somashekar BV, INDIA
Sponsored Links

  #3  
Old 12th March 2012, 04:18 PM
kakoni kakoni is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Mar 2012
 
Posts: 5
Thanks Given to Others: 0
Thanked 2 Times in 2 Posts
Karma Power: 9
Karma: 20
kakoni has less than 100 Karma points so far.
Re: What constitutes (is defined as) as a Medical Device?

Quote:
In Reply to Parent Post by somashekar View Post

A device is a medical device if the manufacturer so intends ...
So glooko is making it for the iphone guy or the bg meter guy ?
If the bg meter guy, then its an accessory for his medical device and can so be classified.
So, Mr kakoni, welcome to the cove and tell us if you represent glooko, or the iphone company or the bg meter company.
Hi Somashekar! No I dont present glooko / bg meter / iphone company. Im currently only using them in my daily life.

Now back to my question; I am researching this phone / medical device connectivity field and trying to understand the regulatory requirements that are related to it.

Thanks.
  #4  
Old 12th March 2012, 05:46 PM
Ronen E Ronen E is offline
Glad to help, if I can

 
Registration Date: Mar 2010
Location: Western Australia
 
Posts: 1,796
Thanks Given to Others: 1,611
Thanked 1,025 Times in 719 Posts
Karma Power: 213
Karma: 8965
Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.
Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.
Re: What constitutes (is defined as) as a Medical Device?

Quote:
In Reply to Parent Post by somashekar View Post

A device is a medical device if the manufacturer so intends ...
So glooko is making it for the iphone guy or the bg meter guy ?
If the bg meter guy, then its an accessory for his medical device and can so be classified.
So, Mr kakoni, welcome to the cove and tell us if you represent glooko, or the iphone company or the bg meter company.
Hi,

In my opinion it depends on the iPhone application's intended purpose. If it is marketed as having any therapeutic or diagnostic value (purpose) then I'd say this connector is an accessory to a medical device, and the application itself is a medical device.

Cheers,
Ronen.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Other Medical Device and Orthopedic Related Topics

Do you find this discussion thread helpful and informational?


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
Diagnostic - Is "diagnostic" defined in the EU Medical Device Standards? Bunny Definitions, Acronyms, Abbreviations and Interpretations 10 6th October 2011 05:50 PM
Universal Medical Device vs. Global Medical Device Nomenclature Systems Bruce Banner Other Medical Device Regulations World-Wide 2 6th April 2011 02:39 PM
How is a Medical Device defined in the EU? Gerry ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2 7th March 2011 05:34 PM
Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging MIREGMGR US Medical Devices (21 CFR part 820) 4 11th November 2009 10:26 AM
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations Al Rosen ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 11 24th February 2007 09:58 PM



The time now is 01:42 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272