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List of Services
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
