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.
 

Timothea

Starting to get Involved
#3
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.
Hi Andrea!

I agree with Yodon - none tool can be a substitute for an understanding of the regulation and requirements.

We were in your position, there are a lot of solutions. In the end, my company uses qmsWrapper. Check them out - they have a free trial. You asked about documentation/processes - software comes with templates for ISO 13485 and with processes also made according to standard requirements. This was very helpful, we used their processes to write our SOPs. Basically, we followed the steps and materialized them on the paper.

Also, the software has other great features - you can do risk analysis, organize your files according to your needs and send them for approval. You can do a lot of stuff on one platform.
 
#4
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.
Andrea:

I agree with Yodon in that you need to have at least a basic understanding of the regulation. That said, a robust software solution can also help SIMPLIFY the burden and complexity associated with navigating regulatory requirements.

When you are assessing software solutions, whether that be Greenlight Guru or any other solution, I always recommend you do due diligence when selecting a software partners: and ask to speak with multiple members of the leadership team working at the software vendors you are considering. Here are some questions to consider asking:

  • Does the company and their leadership team have an online presence and profile? (Linkedin, Glassdoor, etc)
  • Is this a solution and technology that can scale with your team?
  • Establish if the company is an industry thought leader and will likely help you stay ahead of regulatory changes
  • Talk to other people who have used the software along with reading reviews for the software on G2 Crowd and Capterra

Just because a solution is cheap and offers a free trial, doesn't mean that it is the right long term solution for you and your team.

I'd be happy to connect you with a member of our team at Greenlight Guru for a demo of our software in order to discuss how it could simplify the complexity of compliance management for your team.

Mike Gadus
Greenlight Guru
 
#5
Hi Andrea!
I am an engineer in a small medical company and our team was also searching for electronic QMS solution. Since, we are not expertise in QMS, we were looking for software that can help us to manage our daily work and to meet ISO 13485:2016 requirements and in the same way to help us through FDA clearance.
In our case implementation or installation time and price was crucial. Our search according to these two main criteria took months of testing and watching demos.
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.
Mike's question can be helpful, but don't judge according to price and free trial. If something is cheap, it doesn't mean it is wrong. Keep your team, product and regulatory needs first
 
#6
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?
 

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