Postmarket Risk Assessment Form
Evaluate and document postmarket risks for your product or service. Please provide detailed and accurate information for each item.
Product or Service Name
*
Date of Assessment
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Describe the Identified Postmarket Issue
*
Risk Evaluation Matrix
*
Rows
Likelihood
Impact
Current Risk Level
Rare
Unlikely
Possible
Likely
Almost Certain
Negligible
Minor
Moderate
Major
Critical
Severity Rating
*
Low
1
2
3
4
High
5
1 is Low, 5 is High
Frequency of Occurrence
*
Isolated
Occasional
Frequent
Continuous
Affected Users or Areas
*
Actions Taken to Address the Issue
*
Follow-up or Monitoring Required?
*
Yes
No
Additional Comments or Notes
Submit Assessment
Should be Empty: