Iec 62304 Checklist Xls _best_

Formalize how bugs are reported, analyzed for root causes, and resolved. www.qualityfwd.com Recommended Excel Template Columns

Specific measures to mitigate identified risks. Verification: Evidence that control measures actually work. 3. Configuration & Problem Resolution (Clauses 8 & 9) Iec 62304 Checklist Xls

Define roles, responsibilities, and external system interfaces. 2. Software Requirements Analysis (Clause 5.2) Formalize how bugs are reported, analyzed for root

Dr. Maria Rodriguez, a seasoned medical device software engineer, had just been assigned to lead a project to develop a new software-controlled infusion pump. The pump would be used to deliver precise amounts of medication to patients in hospitals and clinics. Software Requirements Analysis (Clause 5

2, 4.2, "Assign roles and responsibilities", Management, "Document responsibilities for software lifecycle activities", "Organizational chart, RACI, role descriptions", "Roles assigned and communicated", Not Started, Project Manager, , , Low,