QMS for medical device startups

#1
Can someone please suggest the best suitable QMS software for medical device startups? I mean something that meets requirements as per ISO 13485:2016 and is not so expensive.
 
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yodon

Staff member
Super Moderator
#2
{rant alert} QMS software packages are not silver bullets. You can use them in ways that are non-compliant. {end of rant 1}
{start of rant 2} Costs go well beyond purchase price. You need to ensure resources are available to tailor and maintain. {end of rant 2}
{start of rant 3} Purchasing a package without understanding your use, needs, or requirements leads to a disaster. {end of rant 3}

It wouldn't necessarily be a bad idea to start without a package while you get your basics in place. That helps you understand the processes.

All that said, I've had several startup clients successfully using a variety of packages: QT9, QCBD, and Verse Solutions (a spinout of eTQ). (I have no ties to any of those companies).
 

Watchcat

Trusted Information Resource
#7
QT9 and Greenlight Guru
There are a number of people around here who have tried Greenlight Guru. You can find their comments by search the Cove for Greenlight. I found nothing here when I searched for QT9. I dunno, to me that almost inherently makes it suspect.

I took another look at decided QT9 seems more like ISO 9001 software that someone says "and you can use it for ISO 13485, too." I didn't see any design control functionality, which Greenlight Guru has.
 

indubioush

Quite Involved in Discussions
#8
QT9 does exist. I have used it before and we used to joke that it was a "startup" for a "startup," meaning they were a startup software company, and were were a startup med device company. That software had its share of issues, but maybe they have fixed all those by now. :)
 

Enternationalist

Involved In Discussions
#9
I am tempted to mostly agree with the others. Moving between QMS software is pretty rough, and you're unlikely to have your operations down at the early stage. A number of solutions are pretty immature, and the veneer of quality begins to flake off once you actually put a bit of pressure on the system and check the validation for yourself.

In particular, check validation documentation carefully as a lot of things are simply passed back onto you as a "user responsibility". You will still be required to establish procedures that work with such systems.

For ones I have seen or tried; Greenlight Guru has a very strong marketing prescence - my experience is that it is still inflexible and immature as a solution. Verse Solutions seems a bit more mature and robust (if less pretty), but less amenable to updates and changes. I would be very hesitant about investing in them as a startup.

Keep your requirements to the absolute minimum while you are starting. You need your time and resources to go toward making sure your product is up to snuff, not troubleshooting QMS software. A simple cloud-based system with adequate permissions, and a decent way of recording reviews/approvals and signatures is a good start.

Devil's advocate: technology implemented well will save you a lot of hassle. Your biggest stumbling blocks as a new company are often just keeping track of the enormous backlog of tasks required for medical devices - if you are going to invest in anything, invest in non-QMS systems to ensure communication is effective, automatic, and centralised (e.g. something that reminds people they need to review a document, etc.), and that activities are as visible as possible to everyone at all times. Those tools don't necessarily need to be "official" in a quality systems sense; they're just good business and communication.

Spend some time thinking about how to make it easy for people to be compliant, not just your records.
 
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