Description

• Conduct user interviews, gathered requirements and analyzed the requirements.  
• Create the Business Requirement Specification (BRS) and Functional Requirement (FRS) document for the system integration.
• Produce, update, and maintain documentation including project plans and weekly status.
• Prepare Verification & Validation Plan, aligned with business goals, defined, and prepared test cases and functional Verification & Validation test protocols.
• Prepare Analysis document to identify the individual application impact on the instrument.  
• Coordinate the implementation or scheduling of validation testing.
• Generate test cases from requirements documents for medical instruments.  
• Design the business requirement collection approach based on the project scope and SDLC methodology.
• Design and develop Uses Cases & Create the Verification & Validation Protocols for the required modules in the project.  
• Create the Requirement Traceability Matrix for the Test Case tracking.
• Execute test cases and generate execution reports.
• Documenting requirements for evidence gathering necessary for FDA 510K submissions.
• Implement of 21 CFR Part 820 – Quality System Regulations and IEC 62304.
• Conduct workflow, process diagram, and GAP analysis to derive requirements for existing systems enhancements.
• Determine and develop test strategies for Functional Verification and User Acceptance testing.