We need a QMS: file-based templates or software

[bob44]

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!

 

[Al Rosen]

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]

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]

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]

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]

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]

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]

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.

 

[indubioush]

Fully agree with Marc! You should always assume you will be in for the long haul.

 

[Ronen E]

The paper system will also force you to understand quality system requirements.

Doesn't sound like they want to understand, just to tick a box, and for as little as possible.