Version 3.4.0 Release Notes

Ulla Tanskanen -

Version 3.4.0 Release Notes

Release Date: October 2, 2017

The following MDRAP changes were made in the Version 3.4.0 release:

Change 1. Added Manage Organization capabilities for Medical Device Manufacturers (MDMs): added BUSINESS UNITS and BRAND NAMES stratification to enable manufacturers to structure their company according to geographical areas, markets, or products and services.

Change 2. Compare Completed MDISS Assessment: New Compare MDISS Assessment functionality - On Assessments Page, My Organization tab for all completed MDISS assessments:

2-1 Healthcare Delivery Organization (HDO) will have Compare icon for all completed/submitted MDISS assessments

2-2  HDO can Compare against their own organization’s assessment or Average of the Community assessment or MDM assessment

2-3  MDM will have Compare icon for all completed/submitted MDM assessments.

2-4  MDM can Compare against their own organization’s assessments or Average of the Community assessment

2-5  Results – graphical view – will have the option to filter out any Control Category from the graphical display (e.g., control categories can be filtered out by clicking on the controls listed across the top of the graph; represented by non-solid circles).

2-6  Results page will indicate how many assessments are compared.

Change 3. Ability for HDOs to add MDS2 or MDM assessment types and manufacturers restricted to creating only MDM or MDS2 assessments.

Change 4. MDS2 dialogue upload fixes :

  • Close calendar after selecting Document Release Date.
  • Align Software Revision input with Document Release Date input.

Change 5. Changes to Level of Effort (LOE) and Risk on Results graph:

  • Risk dimension (size of bubble) has been renamed “LOE”
  • “Impact” dimension is now x axis, and Likelihood of Exploit is y axis.

Change 6. Limit MDM viewing of MDS2s to only the MDS2 Forms for their claimed/associated products (MANUFACTURER CLAIMS tab):

  • MDM users will be able to view MDS2 Forms in the MDS2 Library for only the devices that are associated with their MDM.
  • If no manufacturer(s) yet claimed by MDM, the MDS2 Library will display note indicating same.

Change 7. Restrict ability to edit or delete a MDS2 Form in the MDS2 Library to the manufacturer organization associated with the device or to MDISS staff with SuperAdmin privileges.

Change 8. Add pagination and row count (50 items per page) to MDS2 Library view.

Change 9. Add ability to filter by manufacturer for MDS2 Library view.

Change 10. Add ability to restrict user request for completing a Pre-Procurement Assessment (PPA) if the manufacturer has already completed and submitted an MDM assessment for that device. The user will get a notification that the device has been assessed by the manufacturer and will be provided with a link to the submitted MDM assessment.

Change 11. Changes to Assessment PDFs:

  • PDF and Grid icons added to Assessment icon options.
  • Assessment reports can be viewed as a HTML page for all unsubmitted assessments.
  • For all submitted assessments, the reports can be viewed/downloaded as a PDF file.
  • MDM/MDS2 assessments will have the MDS2 Form to download as a PDF (Grid icon).

Change 12. The navigation bar across the top of the page opens the dropdown list when hovering over the Administration tab.

Change 13. Changes to Manage Sharing functionality in Administration Tab for both HDOs and MDMs:

  • HDOs - default will be set to "Do Not Share with the Community. All Data will remain private. Organization Admin can change the setting to "Share Assessment Reports with the Community. Only institutionally de-identified data will be shared."
  • MDMs - default will be set to Share Assessment Reports with the Community. Setting cannot be changed.
  • Manage Sharing pop-up box for both HDO and MDM users will include a Note: "* Completed Manufacturer Assessments and MDS2 forms are automatically shared with the community."

Change 14. Add Survey Form filter on Assessments list.


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