U.S. FDA Regulatory Consulting

Where FDA Strategy
Meets Digital
Health Innovation

Black Squid Inc. is a U.S.-based regulatory and strategic consulting firm focused on medical devices, digital health technologies, FDA market access, and healthcare commercialization.

We support startups, OEM manufacturers, and global healthcare companies navigating the U.S. regulatory landscape — from early-stage regulatory strategy through FDA submission and market entry execution.

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10+
Years combined experience
510k
Submission expertise
FDA Medical Device Regulatory Consulting
Digital Health & Software as a Medical Device (SaMD)
AI/ML Regulatory Strategy & Cybersecurity
U.S. Agent & FDA Registration Support
ISO 13485 Quality Management Systems
USC
Partnered with
USC Regulatory Science Center

About Black Squid Inc.

Bridging Technical Development with Practical Market Strategy

Our expertise combines regulatory affairs, business development, product commercialization, and digital healthcare innovation, allowing us to bridge technical development with practical market strategy.

We are one of the first FDA Software as a Medical Device (SaMD) and Cybersecurity Compliance focused consulting companies — bringing first-mover expertise to emerging technology submissions.

01
FDA Medical Device Regulatory Consulting
510(k), PMA, Q-Sub preparation and FDA communication support
02
Digital Health & SaMD
AI/ML, cybersecurity, IEC 62304 and FDA digital health guidance
03
U.S. Market Entry & Commercial Advisory
OEM strategy, U.S. Agent services, global market access planning

Expert Guidance, Real Results

Seasoned Consultants.
Hands-On Experience.

Partnered with the USC Regulatory Science Center, our team brings over 10 years of FDA and international regulatory experience — with proven success across startups and global manufacturers.

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Seasoned Consultants at Black Squid Inc.

Our Services

Regulatory Expertise
for Every Stage

From pre-submission strategy through FDA clearance and beyond — we deliver practical, commercially aligned regulatory solutions.

01

Medical Device Regulatory Consulting

End-to-end regulatory pathway assessment, product classification, predicate strategy, 510(k) drafting, and FDA communication support for Class I, II, and selected Class III devices.

510(k) PMA Q-Submission UDI & Labeling
02

Digital Health & SaMD

Expert guidance on AI-enabled medical devices, clinical decision support, cybersecurity compliance, IEC 62304 software lifecycle, and FDA digital health guidance interpretation.

SaMD AI/ML Cybersecurity IEC 62304
03

Quality Management Systems

ISO 13485 QMS establishment and internal audit services designed for startups — minimising cost and delay on the path to market approval.

ISO 13485 MDSAP 21 CFR 820 Internal Audit
04

U.S. Agent & FDA Registration

FDA establishment registration, device listing, U.S. Agent representation for foreign manufacturers, annual renewal management and import/export guidance.

U.S. Agent Registration Device Listing Import
05

Food & Supplement Compliance

Food facility registration, dietary supplement label review, structure/function claim assessment, and FDA labeling compliance for U.S. market entry.

Food Facility Label Review Supplement Claims
06

Strategic & Commercial Advisory

U.S. market entry planning, OEM partnership strategy, distributor guidance, investor due diligence support, and regulatory risk evaluation for acquisitions.

Market Entry OEM Strategy Due Diligence

Why Black Squid

Practical Expertise
Not Template Consulting

We combine deep FDA regulatory knowledge with real cross-functional experience in engineering, quality systems, and commercialization. Unlike template-only consultants, we deliver strategies aligned to your specific product and market context.

Our experience spans startups to global manufacturers — across disposable devices, digital health products, AI-enabled technologies, and interventional systems.

  • Real-world FDA regulatory experience across device classes
  • First-mover expertise in SaMD, AI/ML, and cybersecurity submissions
  • Partnered with USC Regulatory Science Center
  • Cross-functional understanding of engineering, quality, and commercialization
  • Execution-focused — not just advisory
  • Experienced with OEMs, startups, and international partners
  • Strong U.S. market entry strategy track record

Ready to Begin?

Let's discuss your regulatory pathway

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Case Study

Cognitive Leap · 2022

VRAT System —
VR-Based ADHD
Diagnostic Platform

A first-of-kind SaMD combining virtual reality, AI machine learning, and ADHD diagnostic functionality — guided through the full FDA 510(k) process from zero quality system to final submission.

Project Overview

5
Regulatory work streams
2022
New FDA CRA requirement
SaMD AI / ML 510(k) Cybersecurity QMS IEC 62304

Challenge

"Navigating new 2022 FDA cybersecurity and AI/ML requirements before industry templates existed."

Our Approach

From Zero to
FDA Submission

We built Cognitive Leap's regulatory infrastructure from the ground up — establishing their QMS, navigating first-of-kind AI/ML and cybersecurity documentation requirements, and compiling the complete 510(k) package.

  • 1
    Regulatory Pathway Assessment & Strategy
    Classified VRAT as a Software as a Medical Device with AI/ML functionality. Established 510(k) predicate strategy and defined intended use and indication for use language aligned to FDA SaMD expectations.
  • 2
    Quality System Establishment (21 CFR Part 820)
    Built Cognitive Leap's Quality Management System from the ground up — covering design controls, software V&V protocols, change management, and complaint handling under FDA 21 CFR Part 820.
  • 3
    FDA Cybersecurity Risk Assessment (2022 Requirement)
    Conducted a full Cybersecurity Risk Assessment in compliance with newly mandated 2022 FDA guidance — covering threat modelling, vulnerability analysis, and security control documentation.
  • 4
    AI/ML Regulatory Documentation
    Implemented documentation per FDA's AI and Machine Learning in SaMD guidance — addressing algorithm transparency, performance monitoring, and predetermined change control plans (PCCP).
  • 5
    510(k) Compilation & FDA Communication
    Compiled the complete 510(k) submission package and managed all FDA communications — positioning VRAT as a novel yet substantially equivalent SaMD in the digital therapeutic and cognitive assessment space.

Key Achievements

Pioneering
First-of-Kind Submissions

Black Squid guided Cognitive Leap through a submission that required navigating multiple new 2022 FDA requirements simultaneously — demonstrating our unique readiness for emerging digital health technologies before established industry templates existed.

SaMD Classification & Predicate Strategy
Successfully positioned VRAT within the FDA SaMD framework — establishing clear intended use boundaries and predicate equivalence for a genuinely novel product category.
QMS Built from Startup Stage
Comprehensive quality system established under 21 CFR Part 820, providing Cognitive Leap with a scalable regulatory infrastructure beyond the initial submission.
2022 Cybersecurity & AI/ML Compliance
Completed both FDA Cybersecurity Risk Assessment and AI/ML documentation requirements simultaneously — meeting new standards before broader industry guidance was fully established.

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Schedule a Free
Strategy Consultation

Whether you're a startup developing a first SaMD product, an international manufacturer entering the U.S., or an established company managing a change assessment — we're ready to help.

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Strategy Consultation