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System for Compliance Management (Medical Device)

#1
Dear all,

I am looking for a list of robust compliance management systems to be used for medical devices.
Something that can help addressing "must have" documentation/processess for a specific device profile.
I found bsi Compliance Navigator and Greenlight Guru and I was wondering if something else exist on the market.

Any experience with this kind of systems?

Apologies in advance if I Inadvertently created a thread already existing somewhere else.

Thank you in advance.
 

yodon

Staff member
Super Moderator
#2
There are, indeed, a number of discussions on merits of this or that tool. Be aware, though, that a tool is no substitute for solid understanding of the regulations and requirements.
 
#3
Thanks all for supporting your thesis with practical examples, it is exactly what I was looking for.

Honestly, the persistent search has been paid of. We have found a cheap solution with no installation or any special server requirement and now, we are happily ISO 13485:2016 certified and has 2 FDA 510(k) clearances behind the back.
Sandra, would you be willing to point me to the same solution you found?
 
#5
According to one of the users I talked to, QMSWrapper was a suitable solution.
Not perfect of course, but it helped them being ISO compliant and get FDA clearance so I'd say that it is good enough.

What I have also seen is Stendard (stendard.io) which is a online platform that allows to crate a QMS (and related SOPs needed for medical devices) in under 30 minutes (I have seen it real time).

Now, that being said, it's always important knowing what we are doing and why we are doing it!
 
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