27th November 2019

Toronto, CA - QmsWrapper, a world-famous QMS System that helps Meddev startups and small businesses achieve and manage ISO 13485:2016 and 21 CFR 820, announces that the future is now available with the latest release where vision meets functionality. 

Vs6.0 will radically change the way you look at QMS. It moves away from being simply a traditional QMS, and helps move it to a steroid infused system to help them build their FDA and CE Mark Submissions – after all, this is what it’s really all about!

This is a massive transformation that includes 4 major upgrades.

It will successfully guide companies through the growing demands of risk-based design of medical devices and for those seeking CE Mark, and the looming MDR 2020!

First impression from one of qmsWrapper’s clients on these upgrades:

“I thought it was already one of the best QMS systems out there, but this new version really takes it to another level…”

 Bill McD. independent QMS consultant


1. Now integrated with Jira!


“qmsWrapper got its name because it originally designed to ‘wrap’ Jira in a QMS blanket, to take advantage of the best Agile development system and combine it, “wrap” it together with the best QMS system” – points out Drazenka Z. project manager qmsWrapper.

qmsWrapper and Jira software


Jira Issues and projects are linked to our software, so everything is visible in qmsWrapper. Jira tasks can be tracked and used in “Wrapper” processes seamlessly.

This integration will help medical device companies reduce their development risks and increase their agile effectiveness, whilst still keeping an eye on quality.


2. Traceability Matrix (TM), now the backbone of your FDA and CE Mark Submissions

Traceability Matrix icon


Imagine a TM so effective and useful that it serves as the dashboard to your product development leading to the submission. It’s also the cornerstone of your Design History File (DHF) and Technical File (TF). Supercharged and 

MULTIUSER enabled, TM becomes a team effort. Link requirements to tasks, tasks to testing, testing to validation, all linked to Jira. 

“When we started using TM, the first thing we realized was how easy it was to identify gaps in our submission,
the second,
was how we were able to connect it to life-cycle {IEC62304} requirements,
saving us a lot of work. I’d never do another submission without it…”

Peter R. CEO from Novatis Medical


3. A new Risk Analysis Module (RAM) to support risk-based design


RAM is designed to meet the demands for risk-driven design in medical devices. It can be used either integrated into the TM to address each requirement or as a stand-alone module to help you address more general concerns. Its purpose is to help you document controls that were likely included in the requirement, that by design, controlled a hazard. Design decisions can now be linked to how hazards were mitigated before they became hazards.

Risk Management steps

“…we were able to identify mitigated hazards which were implemented as requirements by design. This helped us document our design decisions.”

Diane M., a first adopter of qmsWrapper


4. Enterprise-grade Processing Engine


qmsWrapper’s core functionality was transformed from a tasks-based system to an enterprise-grade Processing Engine – to better support and enable your business workflows. Along with the Process Editor, business and QMS workflows, processes and procedures, is now more effective, flexible and adaptable. It drives the way your company works from the upgraded modules of TM, RA, and Jira, but also to the existing Document Management and Controls, team messaging, approvals, now all driven to support your business processes. Brings all the parts together, connecting the “dots”, but it’s unseen to users.

 “I can create effective workflows easily with the new process editor.”

Nick L. Project Manager


qmsWrapper offers free Live Demo’s, that help demonstrate why so many Meddev companies recognize the value and effectiveness qmsWrapper brings to their medical device dreams.

Comments (2)

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Congratulations! Our company already tried this New Risk Module and that will help us a lot with these new MDR requirements. Thanks to your expert, we made the right decision and bought qmsWrapper.
I use Jira for work. Does this mean, that I can use qmsWrapper as an add-on?