ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets

M

meis44

#51
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

I finished my matrix awhile ago, but it's nothing compared to this! Great structure, and I like how functional it is.

Thx,
L :applause:
I realize this thread is from a long time ago. Do you have the cross reference matrix (QSReg, ISO 13485, MDD 93/42 EEC, AIMDD 90/385 EEC, and IVDD 98/79 EC). Thank you in advance for anything you are able to provide!:thanx:
 
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S

Semmi

#52
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Hi!

Is there any information about comparsion between iso 13485:2003 und FDA QSR availible.
I'm really looking forward to recieving some help, cause I'm writing on my master thesis and really need that information + help.

Thx for helping me out.
 

Ajit Basrur

Staff member
Admin
#53
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Hi!

Is there any information about comparsion between iso 13485:2003 und FDA QSR availible.
I'm really looking forward to recieving some help, cause I'm writing on my master thesis and really need that information + help.

Thx for helping me out.
Welcome to the Cove :bigwave:

refer this link - Comparison of ISO 13485, FDA and JGMP for comparison between ISO 13485 and 21 CFR Part 820. This has additional Japanese requirements too.

Additionally, you can do a seacrh and look for many informative posts related to the subject. :)
 

Weiner Dog

Med Device Consultant
#54
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Hi. I was a level II certified medical device investigator for the FDA for over 21 years and am now working as an independent contract international medical device consultant.

I want to comment about the types of medical device products you have to manufacture in order to comply with FDA laws and regulations.

FDA is only concerned with finished products (and certain components/accessories- see below for details).

Unless the circuit boards can function and be sold by themselves as a component/ accessory to finished medical devices (which I know they aren't, because they are a sub-assembly in-process product used by another company to manufacture finished devices), you have to register with the FDA and follow applicable FDA laws and requirements (depending upon product classification) and be periodically audited/inspected by the FDA.

However, since these products are indeed in-process products, you are under the light of the finished product manufacturer not the FDA. This firm will require you to follow their specifications and to advise them of any changes you make to the product, components, suppliers, etc. (usually spelled out under a contract) and may even periodically audit your firm. What the other firm is doing is actually practicing purchasing control operations under 21 CFR 820.50.

Here is some guidance to aid you.

FDA defines a medical device (under the FD&C Act § 201(h)) as:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory which is:

(1) Recognized in the Official National Formulary, or the U.S. Pharmacopoeia, or any supplement to them,

(2) Intended for use in diagnoses of disease or other conditions, or used in the cure, mitigation, treatment, or prevention of disease in man or other animal, or

(3) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary purpose through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Additionally, under 21 CFR 820.3 (l), a finished medical device is any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Remember, if you make components/ accessories which are ready to be used for any intended health related purpose and are packaged or labeled for commercial distribution for such health-related purpose, then you are a finished device manufacturer and have to register and follow applicable FDA laws and regulations. (In this case, the circuit boards are not components/ accessories, but are in-process sub-assemblies.)
 

Weiner Dog

Med Device Consultant
#55
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Besudes component v finished product manufacturing, it also depends on the class of the device (i.e. frequency based on risk). Manufacturers of class III and life sustaining/life supporting class II finished product medical devices get inspected by the FDA more often than those having class II devices or class I devices. Exempt class I devices hardly ever get inspected. However, when I was with FDA, I visited all types of domestic & foreign manufacturers, US importers, repackers, spec developers, contract manufacturers, with all types of medical devices- class I expmpt to class III. REMEMBER THE SCOPE OF EU AND FDA DIFFER. JUST BECAUSE ONE PASSES AN ISO AUDIT, THE SAME MAY NOT BE TRUE FOR AN FDA INSPECTION.
 
D

DesiQE

#56
Re: ISO 9001+ISO 13485+FDA QSReq.

Mr. Ed Kimmelman, Consultant and ISO/TC 210 SC1 Chairman representing AMMI USA once shared a matrix. See attachment.

He also told me that QSR is Quality System Records and it should be FDA QS Regulation (820).

I hope Mr Ed does not mind that his matrix is shared by all.
i am unable to download this. Could you please reattach? thank u.
 
J

Juan Dude

#57
Re: ISO 9001+ISO 13485+FDA QSReq.

i am unable to download this. Could you please reattach? thank u.
I just checked the link and it's ok, I downloaded the doc without a problem. If you're at work you may wanna try downloading this at home ;)
 
A

amitkakkar

#58
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Hi,

I am new to this forum and would like to learn more about cGMP. Do anyone have some document to share which can provide some basic understanding on cGMP.

Thankyou.
Amit
:agree:
 

Ajit Basrur

Staff member
Admin
#59
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Hi,

I am new to this forum and would like to learn more about cGMP. Do anyone have some document to share which can provide some basic understanding on cGMP.

Thankyou.
Amit
:agree:
Welcome to the Cove :bigwave:

You can take a look at 21 CFR Part 820 for understaning the GMPs. Besides, the FDA website is a great learning in itself.
 

bio_subbu

Super Moderator
#60
Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

In addition to Ajit’s post, take a look at Was: http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#qsr (Dead) FDA CDRH Learn, you can find online video as well as printable slide presentations.

For understanding FDA GMP check the presentation link Was: http://fda.yorkmedia.com/fda/Viewer/Viewers/Viewer240TL.aspx?mode=Default&peid=dd2d4823-b14a-4e4c-a6d6-0eae43c5ac9c&pid=3e729d98-bb5f-44ca-a556-d9882eb59f4a&playerType=WM7 (Dead) Quality System Regulation 21 CFR Part 820 -Basic Introduction.

Regards
S. Subramaniam
 
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