qmsWrapper

qmsWrapper PM & QMS Software


5 / 5
2 reviews

Who Uses This Software?

Medical device manufacturers, startups who are facing unique challenges with Design Control and Risk Management, and seek to achieve CE mark, FDA 510k or ISO 13485:2016 standard compliance.


Average Ratings

2 Reviews

  • 5 / 5
    Overall

  • 5 / 5
    Ease of Use

  • 4.5 / 5
    Customer Service

Product Details

  • Starting Price
    $995.00/year
    See pricing details
  • Pricing Details
    License includes 5 QMS manager, 20 team user roles + 1GB of free storage
  • Free Trial
  • Deployment
    Cloud, SaaS, Web
  • Training
    Documentation
    Live Online
    In Person
  • Support
    Online
    Business Hours

Vendor Details

  • qmsWrapper
  • www.qmswrapper.com/
  • Founded 2015
  • Canada

About qmsWrapper PM & QMS Software

21st-century QMS, get started in just 5 minutes! Track, manage and organize all your CE Technical Files and FDA Device History Files in a Traceability Matrix. Forms+ Form Editor. QMS Processes +Process Editor. Complete ISO14971 risk assessment. Robust Document Management with version control, approval workflows, SOPs, etc. Quality Manual. Electronic Signatures, and more. Create safer, better, medical devices and get them to market faster.


qmsWrapper PM & QMS Software Features

  • Audit Management
  • Complaint Management
  • Compliance Management
  • Corrective and Preventive Actions (CAPA)
  • Defect Tracking
  • Document Control
  • Equipment Management
  • ISO Standards Management
  • Maintenance Management
  • Risk Management
  • Supplier Quality Control
  • Training Management

qmsWrapper PM & QMS Software Reviews


Very happy to have found, even happier to recommend!

Sep 06, 2017
5/5
Overall

5 / 5
Ease of Use

4 / 5
Features & Functionality

4 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Extremely
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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.

Overall: 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

Jun 28, 2017
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
Likely
Extremely
Likely