SaMD Complaint Risk Assessment is a Jira Cloud app for triaging software medical device complaints and scoring defect probability, severity, and overall risk. It supports configurable user needs, product requirements, scales, and risk matrices for medical device quality and regulatory teams.
SaMD Complaint Risk Assessment is a Medical & telehealth project. It focuses on assessing medical device complaints consistently and deciding whether they require defect handling or CAPA review. It is built as a B2B product for software as a Medical Device quality and regulatory teams. It is available for free. SaMD Complaint Risk Assessment is available on the web.
Behind SaMD Complaint Risk Assessment is Cahill Consulting Group LLC. Among its 10 catalogued features are complaint triage, defect classification, and probability scoring. It exposes integrations via a public API.
Summary written by a language model from the project’s public pages.
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