Software Hazard Analysis/DFMEA (Starter) Template

The purpose of a Risk Assessment is to identify, evaluate, analyze, assess, and mitigate risks related to patient safety, and patient data privacy and security. 
Try before you buy: Starter templates are available for FREE in our Starter Software Regulatory Kit. These starter templates are only suitable for Class I or Safety Class A devices and therefore are not suitable for FDA or EU regulatory submissions.
View the full version of this template for complete support that is suitable for FDA or EU submission.

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