1. Log In to MDRAP.
2. Click on the Go to Assessments link in the middle of the screen or on the Assessments tab in the blue navigation bar across the top of the screen.
3. From the Assessments page, either Create a New Assessment by clicking on the red circle to the far right of the Assessments search bar, or select an existing Assessment from the list to continue to complete/update.
4. The system restricts assessment types by organization and survey type; HDO users can select only the MDISS assessment, and MDM users can select either the MDS2 or MDM assessment types as shown in the screenshots below.
5. Once the Assessment is selected from the list or orange ADD button clicked, the system will display a list of the control categories and the completion status of the questions in each control category. Select any Control Category, on the left side of the screen to begin or continue answering the assessment questions. Note that the HDO user selected the MDISS Assessment Questionnaire as shown in the screenshot below.
6. The corresponding questions to be answered for the category will appear based on the selected Control Category.
7. Answer (select the response) to the associated questions. Click NEXT button at the bottom right of the screen after answering each question to save the answer and navigate to the next question in the assessment questionnaire. As questions are answered and saved, the progress meter for each Control Category will increment based on percentage complete and filled in accordingly.
NOTE: All Control Category progress meters must be 100% for the Risk Assessment to be considered complete (green SUBMIT button will be shown only when the assessment is 100% complete).
8. Once all questions for each Control Category have been completed, click the SUBMIT button to lock all answers and submit the assessment. No changes can be made to the assessment after the SUBMIT button has been pressed.
9. When opening the completed/submitted assessment by clicking on the assessment name (second column from the left), the completed assessment opens in a new window and a "LOCK" icon is displayed in the Assessment header indicating that the assessment is submitted and all answers are locked.
10. If the organization elects to Share assessments, all SUBMITTED assessments will be made available to all MDRAP users via the Community tab on the Assessments Page (center tab below the Search Assessments search bar in the screenshot below).
NOTE: A 15-day comment period is provided before HDO assessments are shared with the community. The Medical Device Manufacturer MDM is notified that an assessment has been completed and is provided a comment box to share clarifying comments. The MDM comment features are only applicable if the HDO is the sharing organization and only impacts those shared assessments that appear in the community. If the HDO is a sharing organization, a submitted assessment will appear in the community after the 15-day comment period even if the MDM has taken no action. The MDM may not modify the HDO assessment or assessment scoring through the comment process. The MDM has the option to release the assessment (skip the bypass period) with or without comment and allow the assessment to appear in the community immediately. MDM Assessments do not have a comment box and are published to the community immediately upon completion.
The HDO can always see their own assessments and the comment box is always available to the MDM for editing, even after the comment period has expired. An icon has been added to the assessment list to indicate if an MDM comment exists.
NOTE: Assessment results can be viewed via the View Assessment Report and View Results icons without clicking on the SUBMIT button. Organizations can view the results, take remediation actions to improve the security of the device, and edit/update answers to the assessment questions prior to clicking on the SUBMIT button.
You have now completed an Assessment! Completed MDM and MDS2 assessments generate an MDS2 entry and a downloadable file for the MDS2 library.
To understand the risk scoring/results of a Risk Assessment, read View Risk Scoring Results Graph.