5 facts about qmsWrapper
- Did you know that qmsWrapper’s pedigree is a medical device research company?
qmsWrapper is the part of the corporation that is creating a new medical technology heart health-related. Since the company has offices in both North America and Europe, it was complicated enough to communicate, coordinate, and collaborate on the same tasks, events, projects, plus to stay compliant.
Therefore, part of the software development team was heading to create our own quality and compliance app. In the beginning, it was made for us. Made for our use and it was something that we could actually rely on and believe in.
We understand what our clients are dealing with!
2. Did you know we are the only software for medical device companies that applies the MTQ approach?
The Management Through Quality compliance is different because the focus is not on quality as the end game, but rather on quality as the process to achieve compliance.
MTQ means as your team members complete their tasks, they trigger QMS events that get automatically reported to the QMS system where managers can oversee the progress.
The team is working on their task not knowing it is compliance matter, without adding another layer of management and bureaucracy to their daily work.
3. Did you know qmsWrapper is the most affordable QMS software for medical device companies?
qmsWrapper’s subscription yearly license is accessible because our target market is startups and small companies, and we understand the budget matter.
The initial subscription for qmsWrapper includes 25 members.
From our experience, most start-ups and small companies buy licenses only for those people involved in QMS. But we know that the whole team is the key to product and regulatory success.
For this reason, we decided to create this type of license, which will give you the opportunity to include more people and grow your team.
And yet, we manage to stay the most affordable among other QMS software!
4. Did you know qmsWrapper is built to help medical device companies to get through the certification process faster?
Compliance is complex, but complying with regulatory requirements won’t be difficult using qmsWrapper.
The system is built to conform FDA 21 CFR Part 820 and 21 CFR Part 11 requirements and with ISO 13485:2016 and ISO 14971.
5. Did you know qmsWrapper takes care of your data security?
We know that medical device companies produce and upload a tremendous number of files to our storage. Therefore, expect their data to be safe and confidential.
For all these reasons, qmsWrapper uses AWS for back up.
There are many worries while developing a medical device, believe us, we know! But one less. qmsWrapper wants you to feel safe while working.
BONUS FACT
Did you know we are the most reliable QMS software for medical device companies?
How do we know? Because qmsWrapper is validated per ISO/TR 80002–2:2017 Medical device software — Part 2: Validation of software for medical device quality systems standard.
Medical device companies must carefully consider the impact of introducing software applications, particularly where the company needs to demonstrate compliance with regulations and standards. Validating the software helps reduce risk and legal liability.
Talk to our Experts and learn more about qmsWrapper.
If you are a QMS Beginner, and you don’t know Where to start, this is the right place where you can learn more and implement QMS in a few months.
If you already have implemented QMS, but your system is paper-based — it is time for a change. Going Digital is the right choice for you! Transfer your paper-based QMS to eQMS without any struggle.
