Bridge the technical gap between your engineering vision and the meticulous documentation required for regulatory approval.
Services
Comprehensive Design Planning: We establish "Right-Sized" development plans that define roles, resource allocation, and phase-gate milestones, ensuring audit readiness from the start.
Requirements Management: Expert translation of user needs and clinical requirements into measurable, verifiable design inputs and outputs.
Traceability Matrix Construction: Development of matrices that link every design input to its corresponding output, verification, and validation activity.
Verification & Validation (V&V): Ensuring test protocols and reports confirm the device was "designed right" (verification) and is the "right device" for the user (validation) using a risk-based approach for sample sizes and rationale.
Design History File (DHF)/Medical Device File (MDF) Management: Compiling and maintaining a robust DHF (referred to as part of the Medical Device File under QMSR) that serves as the definitive evidence of your controlled development process.
Design Transfer Optimization: Streamlining the transition from R&D to manufacturing to ensure production specifications consistently meet design outputs.
2026 QMSR Gap Analysis: Specialized reviews to ensure legacy design files meet the enhanced risk-management integration and terminology updates required by the February 2026 FDA transition.
Bridge the technical gap between your engineering vision and the meticulous documentation required for regulatory approval.
Services
Comprehensive Design Planning: We establish "Right-Sized" development plans that define roles, resource allocation, and phase-gate milestones, ensuring audit readiness from the start.
Requirements Management: Expert translation of user needs and clinical requirements into measurable, verifiable design inputs and outputs.
Traceability Matrix Construction: Development of matrices that link every design input to its corresponding output, verification, and validation activity.
Verification & Validation (V&V): Ensuring test protocols and reports confirm the device was "designed right" (verification) and is the "right device" for the user (validation) using a risk-based approach for sample sizes and rationale.
Design History File (DHF)/Medical Device File (MDF) Management: Compiling and maintaining a robust DHF (referred to as part of the Medical Device File under QMSR) that serves as the definitive evidence of your controlled development process.
Design Transfer Optimization: Streamlining the transition from R&D to manufacturing to ensure production specifications consistently meet design outputs.
2026 QMSR Gap Analysis: Specialized reviews to ensure legacy design files meet the enhanced risk-management integration and terminology updates required by the February 2026 FDA transition.