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Quality Systems & QMSR Compliance​

Implementing FDA-aligned quality practices appropriate to program maturity

NextPhaseDx works with early-stage diagnostics teams to implement quality system practices that support development under FDA design controls while remaining appropriate to program maturity. Our role is to help teams establish usable, scalable quality practices that enable development activities today and evolve as regulatory expectations increase.

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We focus on integrating quality system elements directly into ongoing development work, rather than imposing stand-alone or overly burdensome systems. This approach supports regulatory readiness while preserving development efficiency and technical flexibility.

Our Expertise

Applying practical quality system implementation to diagnostic development programs

  • Assessment of quality system readiness relative to FDA QMSR expectations
  • Implementation of design control processes integrated with development activities
  • Guidance on document control and risk management practices
  • Alignment of quality system elements with anticipated regulatory pathways
  • Support for quality practices as programs progress toward FDA engagement
Whether organizations are formalizing quality practices for the first time or adapting existing processes to support regulated development, NextPhaseDx provides experienced guidance to help ensure quality systems remain fit for purpose, compliant, and supportive of program progression.
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