I thought that maybe some of you might need this in your jobs. And having spent time making it I thought that I might as well share it. So, here is my table comparing the requirements of 13485, 820 and JGMP. There is probably room for improvement, and if any of you improve it then please upload it again.

:bigwave:

Hi,
Its a great post.I feel it is very interesting and more informative.I too heard that good Manufacturing Practice (GMP) is a set of regulations that defines standards for manufacturing control and quality control of pharmaceuticals and must be followed when manufacturing pharmaceuticals. It was implemented in Japan in 1979 and revised in 1996 to be included in the industry required authorization. We design equipment that is in compliance with the various GMP regulations.Thanks for sharing with us.

Thanks for the comparison - I know this takes a lot of time to put together. It looks similar to the one put together by Ed Kimmelman, but includes the JGMP.

:topic:
By the way, did anyone else have any problem with the file being corrupt? I had to download it and "Open and Repair" in Word to get it to open...

I also had a problem with the file being corrupt. I downloaded it and used the "Open and Repair" feature.

I tried downloading it at home, worked fine. But, then again, I use old versions of Word both places. :)

I was able to open it with word 97, but not word 2003. I fixed the issue with the file and attached it as a pdf file. I can also attach it as a word doc if anyone wants it.

The regulatory definition of medical device is not in 21 CFR 820. It is in the law -- The Food, Drug, and Cosmetics Act.

The regulatory definition of medical device is not in 21 CFR 820. It is in the law -- The Food, Drug, and Cosmetics Act.

That's what's referenced in the matrix on page 11.

Do you have a source for definitions of "active implantable medical device" or "active medical device" other than ISO 13485?

That's what's referenced in the matrix on page 11.

Do you have a source for definitions of "active implantable medical device" or "active medical device" other than ISO 13485?

How about this:

DEFINITIONS - ACTIVE MEDICAL DEVICES

"active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

(90/385/EEC - OJ. L. 189/17)

Active device
The term "active" refers to any medical device that can only serve its intended use with the supply of power by any means including, but not limited to line, battery, or gas power. Examples of active devices include ventilators, pacemakers, and patient monitoring devices. (FDA. A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems).

Implant
Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain therefor a period of 30 days or more. (This FDA definition can be found in various parts of 21 CFR. FDA may include some devices that stay in human body for less than 30 days).

I was able to open it with word 97, but not word 2003. I fixed the issue with the file and attached it as a pdf file. I can also attach it as a word doc if anyone wants it.

Would be very happy, if u could upload the word 2003 version.

BTW: Found another more summarized comparsion of ISO 13485 and FDA QSR:
I'm not allowed to post URL so http://www.medinorma.ch/medtec/downloads/thenewiso134852003v20emedinorma.pdf

what do u think of it?

Bye & Thx

Thank You Gert!

Hello Gert

May be my understanding seems to have its limits. It would be great if you could explain what does the statements in blue mean, in the column of ISO 13485.

But i should appreciate and thank for such a wonderful compilation.

krishna.

Hello Gert

May be my understanding seems to have its limits. It would be great if you could explain what does the statements in blue mean, in the column of ISO 13485.

But i should appreciate and thank for such a wonderful compilation.

krishna.

Hi Krishna,

ISO 13485 is based on ISO 9001.

Thus, those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in normal font.

Where the text of ISO 13485 is not identical to the text of ISO 9001, the sentence or indent containing that text as a whole is shown in italics (in blue italics for electronic versions).

Thus the blue text is an added text for ISO 13485 over ISO 9001.

Would be very happy, if u could upload the word 2003 version.

BTW: Found another more summarized comparsion of ISO 13485 and FDA QSR:
I'm not allowed to post URL so http://www.medinorma.ch/medtec/downloads/thenewiso134852003v20emedinorma.pdf

what do u think of it?

Bye & Thx

Thanks for sharing Semmi :)

Some remarks according the CE process:

In the comments you write ISO/DIS 13485 - "DIS" means draft standard, the correct term is (EN) ISO 13485.

The definitions for the devices are those from the European directives AIMD, MDD and IVDD.

Requirements for labeling are specified in the particular harmonized standards and in Annex I of the directives.

Retention period: Also the standard requires the definition of the retention period depending on the product (for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.4), or as specified by relevant regulatory requirements.)

The ISO 13485 does not require a DMR, but the directives require a "technical documentation" which is more or less equivalent to the DMR.

8.2.1 ISO 13485: If national or regional regulations require the organization to gain experience from the post-production phase. There are such requirements from the MDD: The manufacturer shall institute and keepupto date a systematic procedure
to review experience gained from devices in the post-production phase and
to implement appropriate means to apply any necessary corrective actions,
taking account of the nature and risks in relation to the product. He shall
notify the competent authorities of the following incidents immediately on
learning of them:
(i) any malfunction or deterioration in the characteristics and/or performance
of a device, as well as any inadequacy in the labelling or the
instructions for use which might lead to or might have led to the death
of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics on
the performance of a device for the reasons referred to in subparagraph
(i) leading to systematic recall of devices of the same type by the
manufacturer. This is also a requirement for the quality management system although it is not written in the standard.

I also had problem in opening the word doc. but used your PDF thank you very much.

It is good document & It is really good forum & you guys rocking- keep it up.

Regards, SK

Here's the file in word 2003

The definition really comes from the EU. "Directive 90/385/EEC covers the placing on the market and putting into service of 'active implantable medical devices' (AIMDs)."

This should be the best source for the definition.

Hi Gert! Thank you for the comparison! May I quote it on my study thesis? :-)
Greetings Max

As long as you remember to quote where you got it then I have absolutely no problem with that. Good luck on your thesis.
:bigwave:

Thanks so much for the PDF comparason chart!
Looks useful.
Really good bathroom reading. :p

I thought that maybe some of you might need this in your jobs. And having spent time making it I thought that I might as well share it. So, here is my table comparing the requirements of 13485, 820 and JGMP. There is probably room for improvement, and if any of you improve it then please upload it again.

:bigwave:

Many Thanks, This one is really useful. Do you have similar kind of information for other AP countries like China, India, Thailand, Australia etc..

Regards

Sunil510830

I am sorry, but I have only had to create this matrix, so I can't provide you with the ones you ask about.

Is this matrix comparison still valid? Is there an updated version?:thanks: