We need a QMS: file-based templates or software

bob44

Starting to get Involved
#1
We are a pre-revenue medical device, US-based company with about 6 months to go till finishing pivotal clinical study for eventual PMA submission.
We assume we will be bought out by a bigger fish before we have to commercialize the device.

We need a QMS and are struggling with buying Word/Excel file-based templates for < $1K or spending > $2.5K for software/web based system.

Any suggestions from those who may know better than our guessing?

TIA!
 
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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#2
We are a pre-revenue medical device, US-based company with about 6 months to go till finishing pivotal clinical study for eventual PMA submission.
We assume we will be bought out by a bigger fish before we have to commercialize the device.

We need a QMS and are struggling with buying Word/Excel file-based templates for < $1K or spending > $2.5K for software/web based system.

Any suggestions from those who may know better than our guessing?

TIA!
The canned documents that I've seen are not any good. You'd be better off developing your own.
 

bob44

Starting to get Involved
#3
Al,
So what to use as a guide/help to "develop your own" advice?
No one has any experience with QMS in our group.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Al,
So what to use as a guide/help to "develop your own" advice?
No one has any experience with QMS in our group.
My opinion is to hire someone in the medical device industry as a consultant to help you make wise decisions and guide you.

You say
No one has any experience with QMS in our group.
is a pretty scary thought. Getting an experienced consultant in the medical device industry could cost a bit, but long term could not only save you money but also be important to the success of your company.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#5
Al,
So what to use as a guide/help to "develop your own" advice?
No one has any experience with QMS in our group.
I am in agreement with Marc 100%. You need someone with experience to help develop your system and train your group.
 

bob44

Starting to get Involved
#6
We do have paid consultants to assist with content but for the type of system we are constructing: file-based or "cloud/software" based?
 

indubioush

Quite Involved in Discussions
#7
I agree with everything said about getting someone to help you. When you say "file-based," I'll assume you mean paper-based. Definitely go with paper. It is able be changed easily and you won't have to deal with software validation. Paper is way cheaper. The paper system will also force you to understand quality system requirements. In my opinion, people who don't understand quality system requirements won't be able to put good information into the software system. It has the potential to be a big mess.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
Personally I wouldn't put anything into the cloud, but that's me. I would think your consultant would give you appropriate guidance for your specific situation/scenario. Obviously they are not. That makes me question your consultant(s) capability, or whether your contract is so bare that it's not part of their responsibilities.

To me this is also pretty scary:
We assume we will be bought out by a bigger fish before we have to commercialize the device.
 
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