qmsWrapper Reviews

qmsWrapper

QMS software for Medical Device startups

5.0/5 (3 reviews)

Emma Fortin

Recommend this software

Used daily for 2+ years
Reviewed 2019-07-26
Review Source: Capterra

Pros
I love that they have a good Tractability Matrix that helps our company a lot. Every document is on right place and no more loosing files and problems when it goes to approve. Also, the support team is very kind and always helping when we need some questions.

Cons
We are using this software many years and I don't have any objection about it.

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 10/10

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Jonathan El-Sharkawy

Very happy to have found, even happier to recommend!

Used daily for less than 6 months
Reviewed 2017-09-06
Review Source: Capterra

Project management + QMS Processes to guide you through regulations Templates to populate Massively cost saving Wonderful account management Automated Quality Manual with a gap analysis report

Pros
My company came from MasterControl; we found it hard to use, expensive, and essentially a giant version control system that was quite dated. For a long time we have to run project management separately in Asana, increasing our workload and, even after expensive MasterControl training, leaving us wondering what to do to get our medical device through the certification process. Then I found QmsWrapper QmsWrapper is not only a QMS system and a Project Management tool, but it actually has the processes and templates required to get you through ISO 13485 and an FDA510k build directly into it. This was clearly made by people who have not only been through the process, but recognised how hard it was and the need for a system to help guide one through it. Their support reflects this, as they understand your needs and go above and beyond helping you. The processes explain what you need to do, step by step, giving you templates to download, populate, and upload back into the system. Auditors don't just want to see that you have said you are going to do something, they want proof that you have done it - using QmsWrapper to do your project management, host your meetings, and have conversations in its inbuilt chat program, provide you with just that - proof. It even has an inbuilt quality manual that you configure to your companies needs. You can then run a gap analysis from what you have said you're going to do, and what you have actually done, to find the holes.

Cons
They need a new desktop sync tool, which I believe they are working on, but the biggest issue with the system is that it does not interface with your local calendar. Meetings have to be scheduled all the time, with people on the go, and one must consider that the entire team does not sit in the system. It could also do with a traceability matrix, and better training videos / manuals. My account manager has been fantastic in lieu of this, and I have it on good faith that the matrix is on its way this month.

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 10/10

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Marina Vucetic

Rating only

Used daily for 6-12 months
Reviewed 2017-06-28
Review Source: GetApp

Rating breakdown

Value for money
Ease of use
Features
Customer support

Likelihood to recommend: 10/10

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