When to begin putting together postmarket production QMS for a mobile app?

Watchcat

Trusted Information Resource
#1
I typically work on the premarket/regulatory clearance side of things, so am at best vaguely aware of a company's efforts to prepare for postmarket production. However, I'm well aware that many hardware device startups largely ignore all of the QSR except design controls prior to FDA submission, and many don't start working on the rest until after clearance.

I'm also fuzzy on what it means to "manufacture" a mobile app.

Does anyone have any insights as to when a mobile app startup should start working on the aspects of the QSR applicable to postmarket production? What do they need to have in place first? At what point in the process are they running behind if they haven't started on this already?
 
Elsmar Forum Sponsor
#2
I typically work on the premarket/regulatory clearance side of things, so am at best vaguely aware of a company's efforts to prepare for postmarket production. However, I'm well aware that many hardware device startups largely ignore all of the QSR except design controls prior to FDA submission, and many don't start working on the rest until after clearance.

I'm also fuzzy on what it means to "manufacture" a mobile app.

Does anyone have any insights as to when a mobile app startup should start working on the aspects of the QSR applicable to postmarket production? What do they need to have in place first? At what point in the process are they running behind if they haven't started on this already?
Great topic!

We are gathering information to submit a 513(g). In the meantime, I am working with our QMS provider to ensure that the QMS is aligned with both ISO 13485 and QSR. I have been working on a staff training matrix and would like to steer the developers and clinical folks to ISO 14971 training and get them used to working within regulatory guardrails.

I know everything I have read has QMS post clearance and I think that is madness. We start now.

**If anyone has a training matrix they could share, I would be so happy.
 

yodon

Leader
Super Moderator
#3
prepare for postmarket production
Not exactly a correct term. There's production and then there's postmarket activities.

I'm also fuzzy on what it means to "manufacture" a mobile app.
Not much! The binaries are built and made available. Presumably for a mobile app, you make the executables available through the Apple App Store and/or Google Play.

I know everything I have read has QMS post clearance and I think that is madness.
FDA doesn't require much in terms of postmarket. The EU does but the effort is (ostensibly) commensurate with the level of risk of the device.

I would think you'd want your users to register their app so you can keep track of users in case you need to communicate information, including new release availability.

IEC 62304 (recognized by FDA / harmonized in the EU) does require some monitoring of feedback and issue reports to determine if software changes are warranted. You're providing a product so it makes sense you want to monitor things to see if your software should be updated.

Obviously, there are other things like recalls for which you would need procedures.
 

Watchcat

Trusted Information Resource
#4
Or money. I think in many cases investors aren't willing to foot the bill until the device has been cleared.

And then there are those who are certain that another company that already has QMS in place will acquire them as soon as their "breakthrough, market disrupting, etc" app clears FDA, so why bother. Sigh.

May I ask what "now" is with reference to your app? Has the software been validated?
 

Watchcat

Trusted Information Resource
#5
Not exactly a correct term.
Told you I was fuzzy, LOL. Good point, though. I even sort of understand the difference. I think. You need your production procedures in place *before* you start producing, so post-production is too late to start working on those?

So if not much is needed, is there some reason to get started pre-submission? Does it still take a while, even if the actual amount is not much?
 
#6
Or money. I think in many cases investors aren't willing to foot the bill until the device has been cleared.

And then there are those who are certain that another company that already has QMS in place will acquire them as soon as their "breakthrough, market disrupting, etc" app clears FDA, so why bother. Sigh.



May I ask what "now" is with reference to your app? Has the software been validated?
Starting now in reference to getting our QMS in place, training staff, and having the culture around ISO 13485. We have a couple of pathways - De Novo in addition to a 510(k) with a predicate. It is just a matter of which one the C-Suite wants us to pursue. I am sure our company is not going to be acquired by anyone. We have partnered with some big pharma etc so we are ok if they can make up their mind on which TA to go with
I see your point though. If there is uncertainty in going to market or being gobbled up, is it worth the heavy lifting?
 
#7
Not exactly a correct term. There's production and then there's postmarket activities.



Not much! The binaries are built and made available. Presumably for a mobile app, you make the executables available through the Apple App Store and/or Google Play.



FDA doesn't require much in terms of postmarket. The EU does but the effort is (ostensibly) commensurate with the level of risk of the device.

I would think you'd want your users to register their app so you can keep track of users in case you need to communicate information, including new release availability.

IEC 62304 (recognized by FDA / harmonized in the EU) does require some monitoring of feedback and issue reports to determine if software changes are warranted. You're providing a product so it makes sense you want to monitor things to see if your software should be updated.

Obviously, there are other things like recalls for which you would need procedures.
I am going with the most stringent QMS protocols (ISO 13485, et al.). Once we get FDA clearance, I know they are going to want to dive into other markets so I want to be ready and not scrambling. I am painfully familiar with EU MDR from my previous company and that can't be thrown together as quickly as the execs want things to move.
 
#8
Not much! The binaries are built and made available. Presumably for a mobile app, you make the executables available through the Apple App Store and/or Google Play.
This is also something to consider. Each platform has its own hoops to jump through as well. Apple is not easy to deal with. They want their cut no matter what. Even if you have an app that is free but you get reimbursed from the insurance payor. Apple wants their 30% or whatever it is.
 

Watchcat

Trusted Information Resource
#9
is it worth the heavy lifting?
A bit off topic, but now that you mention it...Various industry players threw a fit when CDRH proposed potential inspections for De novos. One problem was that they were challenged to make a case. No one wanted to bring up the money. So there were some of the usual fall backs...increased development costs stifle innovation. But CDRH revised that part of the Final Rule to specify very limited circumstances for a facility inspection. The one I recall was in the event of a novel manufacturing process, which makes sense to me.
 
#10
I remember reading that recently. Yes, some things just need eyes. Class II apps don't seem to be too pressing for FDA eyes but I don't want my company to rest on their laurels and get lazy and sloppy. I left a company (not SaMD but a different type of med dev Class III) that was like that and it made me sick.
 
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