FDA 510(k) Support

Navigating the FDA 510(k) Process

Quality Commercial Consultants (QCC) helps medical device and SaMD sponsors plan, assemble, and finalize submission-ready 510(k) packages that align with current FDA review expectations. We bring structure, clarity, and traceability to your documentation—so your team can move through review with fewer preventable delays.

How We Help

We support your 510(k) effort with practical deliverables such as:

  • Submission organization aligned to eSTAR and reviewer usability.
  • Evidence mapping and gap identification across required sections.
  • Integration of specialized content (e.g., cybersecurity, AI/ML) into a cohesive narrative.
  • Quality checks for consistency between claims, labeling, risk analysis, and test evidence.
  • Support preparing for—and responding to—interactive review and Additional Information (AI) requests.

Why It Matters

Incomplete, unclear, or poorly organized submissions often lead to review delays. A disciplined structure and clear traceability help reviewers quickly understand your device, your substantial equivalence rationale, and the evidence supporting safety and effectiveness.

If you have a planned submission date (or an AI response deadline), schedule a consultation to review your timeline and the artifacts you already have.

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We provide clear regulatory guidance that meets you where you are today.

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