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Quality Systems & QMSR Implementation​

NextPhaseDx helps start-ups, academic innovators, and diagnostic developers implement right-sized quality systems that meet FDA’s new QMSR, align with ISO 13485, and follow recognized best practices.
We provide hands-on guidance for establishing design- and development-level controls, defining documentation workflows, and integrating traceability and risk management into daily operations.
Our focus is on building sustainable quality foundations — enabling teams to understand, apply, and maintain compliance as their diagnostic programs advance from research through validation and market readiness.

Ensuring Diagnostic Success Through Quality

Our approach integrates practical compliance with strategic growth, ensuring your quality system supports—not slows—innovation.

  • Guidance on implementing QMSR-aligned design and development workflows

  • Support for establishing quality systems that meet FDA expectations

  • Experience applying design-control and risk-management principles within R&D environments

  • Preparation of documentation templates for design history, traceability, and change control

  • Available for SBIR/STTR collaborations to implement right-sized quality systems aligned with FDA QMSR and program requirements.

Whether you’re establishing your first compliant framework or improving existing processes, NextPhaseDx guides your implementation—helping ensure inspection readiness, regulatory alignment, and long-term sustainability.
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