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» Comprehensive Preliminary Regulatory Strategies For Device Development

» Clinical User Needs & VOC Assessments

» FDA Design Control & Design Assurance Implementation & Execution Support

• -We Help Your Team Prepare Your Product's Design Input Requirements
• -We Help Your Team Prepare Your Product's Design Outputs
• -We Help Your Team Conduct Design Verification & Design (Device) Validation (V&V)

» Medical Device Risk Management Expertise & Support Services

• -We Help Your Team Prepare Your Product's Preliminary Hazard Analysis (PHA)
• -We Help Your Team Prepare & Implement Risk Management Plans
• - We Help Your Team Prepare & Update D-FMEAs and P-FMEAs

» Compliant Engineering Change Control Documentation Training & Support

» Support To Establish / Remediate Design History Files (DHFs)

» Regulatory Support For Design Reviews & Independent Reviewers

» Regulatory Support For Design Verification Activities

» Regulatory & Engineering Support For Device Performance Validations

» Process Validation Plans & Implementation Support - IQ, OQ & PQ

» Device Master Record (DMR) Preparation & Review Support