Even amidst the summer season, the dedicated qmsWrapper team continues to work tirelessly on enhancing the software, as expected. The latest version boasts two significant changes, with one of them poised to greatly assist Quality Managers in efficiently organizing their QMS documentation.


Document Management: Folder Structure

The introduction of an advanced Document Management functionality within qmsWrapper's Storage module is the focus of this upgrade. When starting a new project, users can now select from a menu of meticulously constructed folder structures. qmsWrapper has carefully created folder structures that comply with the guidance established by FDA (U.S. Food and Drug Administration) and MDR (Medical Device Regulation).

Users can easily set up a project with the appropriate folder hierarchy using options such as:

  1. MDR – Medical Device
  2. MDR – Software as a Medical Device
  3. MDR – AI project
  4. FDA – Medical Device
  5. FDA – AI Software as a Medical Device

By selecting one of these predefined structures, qmsWrapper will construct the associated folders and subfolders, ensuring that all necessary points stated in the relevant standard are listed and organized into an easily accessible single centralized location.

This advantageous function makes sure that crucial paperwork needed for regulatory compliance is never missed or misplaced. qmsWrapper helps MedTech teams to focus more on innovation and less on administrative constraints, simplifying the organization process, and eventually improving time to market for innovative medical devices.

Users are able to modify the folder structures, add new folders, and delete or change existing ones, allowing for smooth adaptation to the needs of their specific project.


Enhanced traceability through the Publication of File-to-Issue Association

Along with the update to Folder Structure, qmsWrapper also adds a user-friendly improvement intended to promote traceability within the program. In the Storage module, users may easily identify which files are connected to particular issues. An extensive list of all issues related to that specific file is displayed when you click on the issue icon next to the file, making issue management easier and assuring thorough oversight.


The Benefit of QMS Wrapper

The mission of qmsWrapper is to provide MedTech companies with cutting-edge technologies that boost compliance, teamwork, and efficiency. The advantages for users of this significant update are numerous:


  1. Simplified Compliance: Personalized folder structure that is based on FDA and MDR guidance– your ultimate cheat sheet ensuring all paperwork is consistently arranged. This seamless organization paves the way for effortless audits and uncompromising compliance.
  2. Time savings: Teams can spend more time on product development and less time on manual administrative activities by using regulatory-aligned folder hierarchies.
  3. Improved Collaboration: Cross-functional teams may easily access and work together on key project papers thanks to the unified storage system.
  4. Reduced Errors: Using compliant folder structures reduces the possibility of overlooking important documentation, avoiding expensive delays and rework.
  5. Improved Traceability: By allowing files to be linked to individual issues, it becomes easier to trace issues, to detect and fix any possible bottlenecks.


Both new and existing users of qmsWrapper can now avail themselves of these advantageous software functions to streamline their medical device development procedures. The upgrade offers seamless integration of these features, empowering users to optimize their workflow efficiently.

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