Simplify Quality Control
Optimize Your Processes with qmsWrapper
Medical device specialist
Definitely, we can organize better, trace efficiently and manage all our documentation and more. I am very satisfied with it and definitely I would recommend it to my colleagues and people out there involved with the medical device industry.
It builds us a quality manual based on our specific requirement, shows us what processes to implement in order to adhere to said manual, walks us through those processes using project management methodologies, and even gives us the templates we need to populate to be compliant.
Head of Operations
Once again, I just must stress how happy I am that you have managed to find a solution to “preview” a word document without the need to first download. This is such a huge help!
So, thank you! We highly recommend it.
Overall experience is rather positive for the modules that we use. Being a small start-up company, having ISO 134185 to maintain and CE and FDA pending, we are quite happy how we use this software. For the future, we hope they will have more features that will aid us, such as custom forms, so we could completely transfer our work there instead of having to go back and forth between Word and software.
One of the things that we really like is that, in the Storage you can see all the information on one particular document – who created, number of revisions, changes, authors of revision, when it was reviewed, approvals, even the comments why the revision was declined. It takes a lot less time for showing the auditors what we did – one click to the designated folder and you have your ISO13485 required information for that document. Talking about the document control…
according to ISO/TR 80002-2
included default SOP templates and
place, so your quality system can grow
with your team.
that includes 12 main
with one of our qmsWrapper experts.
say about us?