Scope statement for CMDCAS

[DEVigil]

Greetings, Fellow Covers!

I am having a dispute with my NB regarding our scope statement for ISO 13485:2003 (CMDCAS). They insist it must slavishly follow the template that Health Canada recommends in GD 207 for non-IVD devices; specifically that it must include a 'for the area of' statement.

Our current scope statement, which we hammered out in conjunction with the same NB two years ago, is "Design and development, Manufacture, installation, and service of medical device imaging and communication software systems." Essentially, our product offers Picture Archiving and Communication System (PACS)-type functionality.

Somehow, after two years of being acceptable, and after a surveillance (not renewal) audit, [FONT=&quot][/FONT]the NB claims that we need to add 'for the area of __' to the scope. Our software is not limited to a certain clinical scope - it can be used to display and communicate multiple kinds of medical images (e.g., RT, CT, PET scans, etc.) to facilitate whatever you would need to display/communicate them for. We do have a focus area in radiation oncology (which our NB apparently does not understand is distinct from radiology, which is the 'area of' their 'experts' want to add), but the functionality is not limited only to that.

In GD 207, Health Canada does not require adherence to the exact formula provided in their templates (which are, themselves, not exhaustive in terms of possible terms to include). They only 'strongly recommend' the format. Furthermore, there are illustrative examples - and those examples do not include all elements from the recommended templates. There is even an example (B2) with a hypothetical product that includes imaging-oriented functionality that does not have any 'for the area of' language at all. Health Canada plainly recognizes that a single template is not suitable for all use cases.

I've pointed this out, and asked for an explanation for why the current scope statement is suddenly no longer acceptable. Their response has amounted to "The template is mandatory, and we are experts and this is our opinion."

I do not want to limit my scope statement to a single 'area of' when that does not accurately represent the actual scope of the product's use. And I certainly do not accept their claim that such language is mandatory when the guidance document clearly states the template is only recommended, and its illustrative examples do not follow it slavishly. Help?

(P.S. - This entire issue was only communicated to me when I refused to pay the invoice for the recent surveillance audit, which took place over three weeks ago, because I had yet to receive the audit report....)

 

[Ronen E]

Hi,

You sound right, but in my opinion in this case you also have to be wise.

Normally, when one receives bad service the ultimate leverage is changing suppliers. Unfortunately, in the current context it doesn't seem to be a viable option. Seems you are stuck with them and will have to somehow plough through.

Geographically, is a face to face meeting feasible? When people are stuck together in a room they sometimes become more constructive and less arbitrary than over the phone.

How about a wording along the lines of "for the areas of radiology, radiation oncology and similar applications."? The word "similar" might be flexible enough to prevent anyone from being bluntly non-compliant, so that all stakeholders are happy. Perhaps you can find an even better phrasing, since you are exposed to the details. I know it might seem like trying to dodge the system, but you've actually already tried the factual / rational approach and it seems to be failing. Besides, the whole thing seems to be a non-essential feature so it boils down to satisfying some stubborn bureaucrat.

Just my

Ronen.

 

[Sarah Stec]

Howdy,

So you're right that a guidance document isn't The Word. But Health Canada sometimes acts like it is, and everyone has to fall in line.

HC Registrars are audited against their adherence in applying the guidance documents. A couple years ago HC started to really enforce the certificate scope provisions because some high percentage (I think a bit more than half, but that's off the top of my head a couple years after the fact) of the certificate scopes didn't conform to the GD 207. So your HC Reg may be reacting to their own nonconformities.

Another way to think about it: ISO 13485:2003 under CMDCAS is a regulatory requirement for HC, and so the certificate and scope needs to respond to the regulations (unlike "vanilla" ISO 13485:2003 by itself). The CMDR requires that the manufacturer include the purposes and uses of the device in its device license application. HC wants conformity between the device license and the QMS scope. If the manufacturer's QMS produces devices for a purpose different than that for which the manufacturer is applying for a license, how can HC assess if the manufacturer's system can produce the device fit for its intended purpose, or know what the real intended purpose is?

If your product is specialized enough to only be used in one area anyway, then you may not need it. Also, I've seen CMDCAS certificates with 5 or 6 areas - you should be able to have as many areas as you're able to support.

I hope that this is helpful!

 

[DEVigil]

If Health Canada's own examples slavishly followed the recommended language, I might be inclined to agree. But they do not. And specifically, they do not for products whose scope isn't tied to particular areas of practice. Ours falls into that kind of category - image processing, display, and communication is useful across a broad spectrum. The second I list one, or even a group, I close off others.

The CMDR itself says blessed little about the QMS certificate, other than a discussion of its period of validity and what happens if it expires or is cancelled. Sections 32 and 33 are more about registrars. Presumably, that is why GD 207 exists. And as previously noted, GD 207 itself doesn't back the NB's position.

 

[Sarah Stec]

Health Canada likes to interpret their own guidances, so you could also ask Health Canada for clarification.

Here's the address if the hyperlink doesn't work: https://www.hc-sc.gc.ca/contact/dhp-mps/hpfb-dgpsa/mdb-bmm-eng.php.

Try and make this call anonymously (i.e. don't give them any identifying information) if you can.

 

[DannyK]

DEVigil- I am a CMDCAS auditor and I would not have an issue with your scope.

From what I remember, the scope is manufacturer's responsibility and it is not the certification body's responsibility to make changes to the scope.

I would tell the certification body that if Health Canada has an issue with the scope, you will deal with Health Canada. Let Health Canada reject it.

If they refuse, contact Health Canada and ask them.

 

[somashekar]

A medical device with the same intended use can be operated under various environments, and each such use demands specific requirements being met by that device. So in order to get the clarity it is advised that the scope has "for the area of" clearly stated.
Example .... An oximeter can be for simple use in home area., in clinics, hospital and general ward area, in ICU or OT area, In Ambulance .... Etc.,
No do you see that the area of use differs. Now can you reflect upon your design inputs to see which specific area of use you designed for.
When you put in in the scope, you are defining a medical device usage with more clarity, which the HC expects. Please look at the scope from the point of view of such area, which clearly distinguishes your device for the group of standards it is considering.

 

[DEVigil]

Somashekar,

I do not understand your reply. You seem to be discussing intended use, which is not the same as the scope statement for a certificate. We have a separate intended use statement.

 

[somashekar]

If your intended use statement details the area of use pretty much as I have detailed in my post, CMDCAS wants this said in the scope statement...

 

[DEVigil]

Where a device is used/by whom it is physically used (as in, professional versus home) is a distinct issue from defining a clinical area of practice (e.g., radiation oncology). They are distinct topics with distinct definitions. I am only discussing the alleged need for the latter on a certificate, not the former.