Software Verification and Validation
• Software V&V Planning
• Software V&V scripts and reports
• Software V&V Testing
• Off the Shelf (OTS) Tools Validation
Software Quality Assurance
• Software Compliance Assessments
• Software Quality Assurance Planning
• Development process, SOPs and templates customized to fit your needs and size
Hands-On Consulting In The Regulated Environment
• Software Development
• Risk Management
• Design Control
• Reverse Engineering
• Software Development Process Definition and Training (SEI Level 3)
Design Control Consulting
• Product Development Assessments
• Product Development Process Definition
• In-house Training
• Retro-documentation of existing software following the FDA and ISO regulations
and expectations
Software Risk Management
• Software Risk Assessments
• Software Risk Mitigation
• Software Fault Tree Analysis (FTA)
• Failure Modes Effects Criticality Analysis
Other Services
• Documentation Services Following FDA And ISO Regulatory Requirements, And IEEE Standards
• Independent Software Audit
• Clinicals and Regulatory
• Software Section Preparation For 510(K), IDE, PMA & CE Mark Technical File Submission
• Due Diligence
