5 things clients like the most about qmsWrapper
1. Its Traceability Matrix feature
qmsWrapper’s Traceability Matrix has an innovative and unique approach to manage complex medical device products.
Using the Traceability Matrix, users can have a complete overview of their medical device life-cycle and trace requirements through the numerous stages of development.
Traceability Matrix clearly demonstrates the connection between the requirements, its design inputs, validation and verification, risk analysis, etc.
2. Supporting integration with Jira
The combination of Jira with qmsWrapper introduces a system in which MedDev companies are able to track, manage, and organize all CE Technical Files and FDA Design History Files while enabling software development of medical devices.
Jira platform help teams plan, assign, track, report, and manage development projects. But they need much more to stay compliant and to get their device to market.
With qmsWrapper, Jira users can accomplish everything from one place. They will have a complete overview in qmsWrapper of all tasks issued in Jira, and all available functionalities that support their way to compliance.
3. Its Document Management Module a. k. a. Storage
qmsWrapper’s Document Management System includes version control, detailed file histories, file tracking, source tagging, comments, authority control. It allows only authorized users to review and approve documents. The approvals are automatically documented with complete history.
Document Management Module (Storage) is organized per project. The user is always aware of which document is a part of what exact project. The Library folder is included for storing non-project related files.
The access rights can be limited to files stored under the Storage assigning membership to the project or access to the Library.
4. Reliability and security!
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.
qmsWrapper is validated per ISO/TR 80002–2:2017 Medical device software — Part 2: Validation of software for medical device quality systems standard.
Also, all files and records stored under qmsWrapper are safe and secured. We use AWS for backup.
5. qmsWrapper’s team understand and listen to clients’ needs
qmsWrapper is the part of the corporation that is creating a new medical technology related to heart health. We understand what our clients are dealing with and what they exactly need when it comes to quality and regulatory requirements.
That’s why we’re always trying to improve the functionalities of the software and make the compliance process smother.
The latest update included the “Custom forms” feature. It will empower the team to build and design forms based on business needs and to record necessary data easier.
Our clients already recognized the value of the implemented feature and they are amazed by the transparency of gathered data and having a compact overview of it. With the possibility to create various reports based on information collected as well.
“The changes that you’ve described sound exactly like the things that I was asking for …” Andy F., VP Engineer said.
“The new forms of capability looks interesting and has the potential to really streamline our process.” — Holly W.
