FSUB LTD

What FSUB LTD does

FSUB LTD, trading as fsub, is a UK-incorporated private company operating a software-as-a-service platform positioned as a virtual regulatory consultant for early-stage health tech founders. The platform's core product is a step-by-step medical device classification engine that determines whether a product qualifies as a medical device and identifies applicable frameworks — including MDR, FDA pathways, ISO 13485, and NHS-specific standards (DTAC, DSPT, DCB) — while exposing the reasoning at each decision point so founders understand their regulatory position before incurring specialist fees. Supplementary modules include an Inconsistencies checker that flags misalignment between product claims and classification, a Templates library covering ISO 14585 and ISO 14971, a forthcoming Compliance Workspace for automated regulatory documentation, and Captain Reg, a 24/7 text-based AI assistant that handles regulatory Q&A and category confirmation.

The company is led by two founders: Linh (CEO), whose background spans health tech and SaMD product development under ISO 13485, ISO 27001 and MDR with shipping experience across the US, UK and Asia, and Michael (CTO), who comes from automotive cybersecurity (ISO 21434) and ISO 27001 quality infrastructure for safety-critical products. The combined regulatory and safety-critical software pedigree is the company's most defensible asset, and the founders explicitly built the product as the virtual regulatory consultant they wished they had during prior SaMD work.

Commercial activity runs on a three-tier SaaS model: Starter at £70/month for funded startups pursuing certification, Pro from £200/month for growing teams (adding automated ISO templates, NHS frameworks, and priority support), and a custom-priced Enterprise tier for innovation networks and accelerators that includes dedicated account management and quarterly analytics. Distribution is primarily self-serve via the website for the lower two tiers, with sales-assisted "book a call" motion for Enterprise. Marketing is digital-first through the website and LinkedIn, with Captain Reg functioning as both a product feature and an interactive qualification asset. The company has a stated partnership with Imperial College Health Partners for distribution into its health innovator network and runs a design partner program for co-building the product with select founders.

Name

FSUB LTD

Legal name

FSUB LTD

Website

https://fsub.io

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

1–10 employees

Short description

FSUB LTD (fsub) is a UK-based SaaS platform that uses an AI assistant called Captain Reg to help early-stage health tech founders classify their products under medical device regulations — including MDR, FDA, ISO 13485, and NHS frameworks — with plans from £70 per month.

Ownership category

akta.pro rank

Product category

Health Tech Regulatory Compliance Software

akta.pro primary industry

Regulatory Affairs & Submissions FSP (HLAGAOAD)

akta.pro secondary industry

Market Access, Pricing & Reimbursement (Evidence Generation) FSP (HLAGAOAN)

Keywords

• Medical device classification
• Regulatory compliance software
• Health tech SaaS
• AI regulatory assistant
• ISO compliance templates

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Subscription SaaS - Starter: Monthly subscription at £70 for funded startups pursuing certification. Includes product classification, market access strategy, intended use & product description, inconsistency checks, and 24/7 AI assistant access.
2. Subscription SaaS - Pro: Monthly subscription starting from £200 for growing teams. Includes everything in Starter plus pre-built ISO templates with automation, NHS specific frameworks, and priority support.
3. Enterprise Custom Contracts: Custom pricing for innovation networks and accelerators requiring regulatory support at scale with dedicated account manager and quarterly reporting.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

fsub is an AI-powered regulatory classification SaaS platform that helps health tech founders determine whether their product is a medical device and identify the regulatory frameworks (ISO 13485, MDR, FDA, NHS DTAC/DSPT/DCB) that apply to it. The platform is anchored by a 24/7 AI assistant called Captain Reg that answers regulatory questions, an automated classification engine that shows reasoning at each step, an inconsistency checker that flags mismatches between product claims and classification, and a library of pre-built ISO documentation templates. It is sold via tiered monthly subscriptions (Starter £70/mo, Pro from £200/mo, Enterprise custom).

Product overview

fsub is a virtual regulatory consultant platform designed for health tech founders and innovators in early stages. The platform centers on its core Classification service, supplemented by an Inconsistencies checker and a forthcoming Compliance workspace. Additional offerings include a pre-built Templates library and Captain Reg, a 24/7 AI assistant. The company provides three pricing tiers: Starter (£70/month) for funded startups, Pro (from £200/month) for growing teams, and Enterprise (custom pricing) for innovation networks and accelerators.

Differentiator

Problem solved

Functional benefit

Products and services

• fsub Regulatory Classification Platform

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Two partnerships are on record, tiered core and minor.

• Imperial College Health PartnerscoreStrategic or Co-development Partnerfsub works with health innovators through Imperial College Health Partners, providing regulatory guidance to startups and innovation portfolio companies. This partnership is highlighted as a key channel for customer acquisition and validation of the product.
• Design Partners (unnamed)minorStrategic or Co-development PartnerCollaborating with design partners who shape sharper product experiences. Company logo section shows partner logos but no specific partner names are mentioned in the source material.

Scale indicators2 records

Recent moves1 record

Expansion highlights6 records

Emerging players

• Vanta: Compliance automation SaaS (SOC 2, ISO 27001, HIPAA) that uses AI to accelerate evidence collection — overlapping technology stack and PLG DNA but serving IT/security compliance rather than medical-device regulation.
• Drata: Automated compliance platform for SOC 2, ISO 27001, HIPAA and similar frameworks. Comparable as a PLG AI-led compliance SaaS targeting fast-growing startups, though not in the medical-device vertical.

Direct peers

• Rimsys: SaaS platform for regulatory affairs management in medical devices, including global submissions, standards tracking and product registration. Direct overlap with fsub's regulatory-positioning value proposition.
• Greenlight Guru: Specialised eQMS platform for medical-device companies, covering design controls, ISO 13485 and FDA compliance. Closest direct peer to fsub in serving health-tech regulatory workflows, though positioned upstream (post-classification QMS) rather than at pre-classification.
• Qualio: Cloud eQMS built for life-sciences and medical-device teams, including ISO 13485, ISO 14971 and FDA workflows. Comparable in targeting early-stage and scaling health-tech companies for regulated documentation.

Broad incumbents

• MasterControl: Established enterprise QMS platform serving life sciences with document control, training, CAPA and ISO/FDA compliance modules. A broader incumbent that overlaps in regulatory documentation but spans much larger organisations.
• ComplianceQuest: Cloud QMS and regulatory compliance platform with explicit life-sciences and medical-device modules, competing for the same ISO 13485/MDR-driven documentation workloads fsub addresses.

Others

• NAMSA: Medical-device-focused contract testing, regulatory and quality consulting organisation. Represents the traditional incumbent service model fsub's AI tool is partially displacing for early-stage founders.
• Maetrics (now RQM+ / 1580 Limited): Regulatory compliance consultancy for medical devices, pharma and IVDs — a traditional services competitor whose early-stage classification and market-access engagements are directly substitutable by fsub's SaaS.
• RQM+: Medical-device regulatory and quality consulting firm covering MDR, IVDR, FDA submissions and post-market activities — the human-consultant alternative fsub competes against for early-stage classification and strategy work.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/fsub

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FSUB LTD