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510(k) · PMA · FDA Strategy · Warning Letters

Regulatory Assistance
That Gets Results.

From pre-submission strategy through 510(k) preparation, FDA 483 responses, and software validation — we deliver the regulatory expertise that moves your device through FDA review.

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Overview

Regulatory strategy is the single most consequential decision a medical device company makes. The right pathway, properly executed, saves years and millions of dollars. The wrong one — or a submission that doesn't anticipate FDA's questions — can stop a program entirely. Mansour Consulting brings 30 years of direct FDA experience to every engagement.

Strategic Regulatory Planning

Before a single page of a submission is written, we work with you to define the optimal regulatory pathway for your device.

  • Device classification and predicate identification (510(k))
  • De Novo and PMA pathway analysis
  • Pre-submission (Q-Sub) meeting preparation and strategy
  • Predetermined Change Control Plan (PCCP) for AI/ML devices
  • Combination product classification and pathway
  • International regulatory strategy (EU, Canada, and beyond)

510(k) Submission Preparation

We prepare complete, high-quality 510(k) submissions designed to minimize FDA questions and accelerate clearance.

  • Predicate device selection and substantial equivalence argument
  • Indications for use and device description
  • Performance testing section (bench, animal, clinical)
  • Software documentation per FDA guidance (IEC 62304)
  • Sterilization, biocompatibility, and labeling sections
  • eSTAR format preparation and submission via CDRH Portal

We also assist with responses to FDA Additional Information (AI) requests to keep your review on track.

FDA 483 Observations & Warning Letters

An FDA inspection finding or Warning Letter demands a credible, thorough, and timely response. We have extensive experience crafting responses that satisfy FDA and avoid escalation.

  • Root cause analysis of each observation
  • Corrective action planning (CAPA) and documentation
  • Written response drafting — clear, factual, and complete
  • Mock inspection preparation
  • Ongoing FDA correspondence management

Software & Validation

Software is increasingly scrutinized in FDA submissions. We prepare software documentation aligned with current FDA expectations.

  • Software level of concern determination
  • Software description and hazard analysis
  • IEC 62304 lifecycle documentation
  • Validation protocols and reports (IQ/OQ/PQ)
  • Cybersecurity documentation per FDA premarket guidance
  • AI/ML-based Software as a Medical Device (SaMD) documentation