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EQMS for small medical device company

Teyla

Starting to get Involved
#1
Hello everybody.
First of all, I hope you're well in this tough situation.
Stay safe and cheerful. We'll overcome this.
Since, I'm working from home and the business slow down, I have time to explore software for implementing the QMS according to ISO 13485 and FDA 21 CFR part 820.
Going paper-based isn't a good option. Especially when it comes to such situation. Also, the importance of staying in touch with the team is immeasurable.
Can anybody recommend the platform for implementing complete QMS with integrated chat?
I looked the Capterra and GetApp, but I'm so lost. Don't know from where to start.
Thank you in advance.
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Hi Teyla.
for a med Device company I recommend going with one of the established suites that offers Part 11 validation
In my last company, which was pretty small, I was considering these:
Q-Pulse
UniPoint
TrackWise
QT9

I was ready to move ahead with UniPoint but it was never funded by the company and then I chose to move on.
My new company has Q-Pulse and I'm liking it so far.
 

yodon

Staff member
Super Moderator
#3
In addition to what @ScottK posted, I've seen Verse and thought it was pretty good.

A recent discussion mentioned BPA Quality. It's built off of Microsoft's SharePoint and so you get Teams as a collaboration platform. That's the only one I know with integrated chat (I guess depending on what that really means).
 

Ronen E

Problem Solver
Staff member
Moderator
#5
If you search Elsmar for eQMS you'll find several threads with quite a lot of info in them.

In general, successfully setting up and breaking in a new eQMS (or a new QMS) will be labour-intense, require team collaboration and I doubt it can be done well remotely. Not sure that this uncertain time is a good one for such a venture.
 

James

Involved In Discussions
#6
I'm currently setting up iPassport in similar circumstances, I know similar organisations to mine that use it effectively. Feel free to DM me for specific questions, etc. I'm using WebEx to discuss system implementation with various groups of staff. Working ok thus far. Keeping the QMS platform separate to the implementation / chat tools is the way to do it I think... I'll be doing some training videos for staff too

James
 

sagai

Quite Involved in Discussions
#7
I do not get any commission on this, however, there is another one that I would recommend:

It is a ALM and eQMS with pre-configured application tempaltes for medical industry.
One preconfiguration is for medical software engineering and eQMS, another one is for Audit and CAPA management and eQMS.

INTLAND Retina ALM and eQMS with Medical device design templates


It can be hosted on cloud that is handy for smaller organization or can be deployed on premise.
 

anbknaga

Starting to get Involved
#8
I tried searching in the forum but felt directionless on this and hence asking it here.

"How do I develop my own eqms for a small medical device company?" We have the engineering resources but is there any standard or guide that could help us design an eqms suite for my company?
 

Jeffbbt

Starting to get Involved
#9
Depending on your budget, I would recommend M-Files with Compliance Kit, or a Wiki, as famously detailed by Pancho in this forum. But there are really a lot to choose from these days. MasterControl, GreenLight, qmsWrapper,

There is not really a standard guide, however I would recommend ISO 80002 which details the software validation requirements. Many of these companies issue a kit or software that is already a QMS bundle and you will just need to explore. Reach out to a sales rep and ask for a demo.
 
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