What is a reasonable MDSAP cost?

Mark Meer

Trusted Information Resource
#1
Just got a quote for an MDSAP initial certification, and can't tell if we're being taken to the cleaners or not (it certainly seems high).

- Small company ( <10 employees, one site)
- Two products (Class I & Class IIa)
- Two countries in the scope (US & Canada)

They estimated a 7 man-days audit, and are quoting $32k USD.

Is this reasonable? Seems incredibly high to me given that the actual auditing activities, even at $2k/day, would only be a fraction of this quote!

My cynical side feels like we're being taken advantage of because the Canadian deadline is looming, and it is not feasible to switch CBs at this point! :(

I'd appreciate if others could share what MDSAP is costing them, so I can get a better idea of what the industry is charging.

Thanks.
 
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yodon

Staff member
Super Moderator
#2
From what I've heard (no personal experience), there is no "reasonable MDSAP cost." Indeed, what you cited pretty much falls in line with other quotes I've heard about. I already know of a few products that will no longer be available in Canada for this very reason.
 

Marcelo

Inactive Registered Visitor
#3
From what I've heard (no personal experience), there is no "reasonable MDSAP cost."
Agreed. Prices range from what you mentioned, some 30k, to 80k, from what I've seen.

Price is right now the main problem, in my opinion, with MDSAP. One of the reasons for these prices is that all AOs are big enterprises that have to maintain costs (including that office in Botswana :p), and they say that the MDSAP maintenance is more expensive than other (might or might not be true).

I will probably request MDSAP recognition in the near future for my AO, with a view of offering quality and speedier service with cheaper costs, but unfortunately this does not seem to be the focus of the other AOs.
 

Mark Meer

Trusted Information Resource
#4
...One of the reasons for these prices is that all AOs are big enterprises that have to maintain costs (including that office in Botswana :p), and they say that the MDSAP maintenance is more expensive than other (might or might not be true). ...
Again, my cynical side would argue that much of the costs are due to the lack of competition and "captive audience" (high cost - or outright inability - to switch CBs), that essentially allows MDSAP CBs to charge whatever.

The MDSAP program, as far as I'm aware, only lays out how audit-durations are calculated. Based on company-size, products, and scope of audit, a set number of days is output, and you can then calculate the audit-activities cost based on the CB's audit day-rate (usually anywhere from $1200 - $2000 /day). ...and this is fine. It's all transparent.

Where it get murky is all the rest of the cost (what appears to be 1/2 - 2/3 of the total!).
This appears to be all administrative, set by the CB. This is where I'd like to get a sense of what others charge, as I have no way to know if my CB is over-inflating simply because they've got us over a barrel..
 

Marcelo

Inactive Registered Visitor
#5
Please note that the MDSAP program have AOs (auditing organizations), not CBs (certification bodies), and this distinction is one I've heard some people talk as being more expensive to maintain (that costs to be an MDSAP AO is different than common knows costs of common CBs).

Obviously, this distinction between the names is more a theoretical one, and also, from my experience, costs have no reason to be that much different, but again, that's the justification I've been hearing for some time now.
 

Edward Reesor

Trusted Information Resource
#6
i believe that it has been said that there are only 4 companies that act as AO for Canada, so getting competitive quotes are possible.

Health Canada is modifying the requirements of the AO's in order to reduce the impact of the program. Last Friday I had a personal call with the Executive Director of the Medical Devices Bureau of Health Canada and he didn't seem all that aware of extent of the financial implications. He asked me for more verification of the increased costs (although our AO still has to consider the latest notification and adjustment of the current $10,000 annually).

Please keep in mind that adding more countries (Brazil, Australia or Japan) will increase your costs.

I would suggest that writing your local MP and Health Canada might work to having it minimized.
 

Mark Meer

Trusted Information Resource
#7
i believe that it has been said that there are only 4 companies that act as AO for Canada, so getting competitive quotes are possible.
In theory. But in reality:
1. In my experience shopping around, at least one of these is outright refusing new business (or at least cannot commit to the deadline, or even estimate any schedule). By their account it is because they do not have the resources to meet demand at the moment, and have chosen to prioritize their existing clients. It wouldn't surprise me if other AOs are in similar circumstances.
2. The cost associated with changing registrars can be significant, especially if you've got a generally good relationship with your current registrar.

In my opinion, 4 over-burdened AOs hardly lends itself to a competitive market. I'd love to see at least a dozen, but I'm not holding my breath that this will happen anytime soon...

I would suggest that writing your local MP and Health Canada might work to having it minimized.
Good plan. Will do. Don't know that most local MPs would have the foggiest idea what you're talking about, but definitely worth contacting Health Canada. :agree1:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
I will probably request MDSAP recognition in the near future for my AO, with a view of offering quality and speedier service with cheaper costs, but unfortunately this does not seem to be the focus of the other AOs.
I wish you very good luck, Marcelo. From what I gather there are 6 recognized AO's and a few more that have not had their applications fully approved yet.

I have very little knowledge of the MDSAP and AO's process, but I have a lot of experience in Conformity Assessment. From my viewpoint, it is CRITICAL that any conformity assessment program needs to keep in mind that confidence to the stakeholders is the end goal and all the actors involved need to be highly competent, so the end result is satisfactory.

In the management system certification sector, the frenzy to request and deliver certificates led to a commoditization and trivialization of the process. Price, more and more, became the deciding factor to select CB's. The pressure to reduce audit fees led to talent leakage and brain drain in the sector, which led to audits of questionable value.

Conformity assessment that delivers confidence to all stakeholders involved come with a price. The type of talent one needs to run a successful conformity assessment body is not easily found. So, before decisions are made to cut price, think of the value this harmonized audits could bring to the manufacturer. If the manufacturer can avoid the disruption of multiple, redundant and inconsistent audits, this has tremendous value for them.

As in my sig line: Sustainable conformity assessment must add value to all stakeholders!
 

Marcelo

Inactive Registered Visitor
#9
I wish you very good luck, Marcelo. From what I gather there are 6 recognized AO's and a few more that have not had their applications fully approved yet.

I have very little knowledge of the MDSAP and AO's process, but I have a lot of experience in Conformity Assessment. From my viewpoint, it is CRITICAL that any conformity assessment program needs to keep in mind that confidence to the stakeholders is the end goal and all the actors involved need to be highly competent, so the end result is satisfactory.

In the management system certification sector, the frenzy to request and deliver certificates led to a commoditization and trivialization of the process. Price, more and more, became the deciding factor to select CB's. The pressure to reduce audit fees led to talent leakage and brain drain in the sector, which led to audits of questionable value.

Conformity assessment that delivers confidence to all stakeholders involved come with a price. The type of talent one needs to run a successful conformity assessment body is not easily found. So, before decisions are made to cut price, think of the value this harmonized audits could bring to the manufacturer. If the manufacturer can avoid the disruption of multiple, redundant and inconsistent audits, this has tremendous value for them.

As in my sig line: Sustainable conformity assessment must add value to all stakeholders!

Hi Sidney, yes, you know I agree with you. My bet is that MDSAP, with regulators as "accreditators", will be able to maintain confidence and quality in a way that, unfortunately, common certification schemes struggle to (and sometimes simply can't) maintain.

On the other hand, MDSAP is probably one of the programs that will (if it solves its problems) turn into pillars of a renovated medical device conformity assessment in the future, as current systems today are loosing sustainability rapidly. Initiatives such as the FDA seeking harmonization to ISO 13485(which is something that most people in the know knew were impossible some time ago) are just creating the basis for that.

Let's see how this goes.
 
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