Fern AI

What Fern AI does

Fern AI is positioned as a comprehensive platform for clinical evidence review that supports medical technology companies with regulatory compliance, speed to market, and quality outcomes. Per the available operational data, the company operates a full-service MedTech contract research organization (CRO) delivering four integrated service pillars: Regulatory and Quality consulting, Clinical Trials management, Lab and Material Science (delivered through the FDA-recognized Jordi Labs subsidiary), and Reimbursement strategy. These services span the full product lifecycle from concept through post-market, addressing complex regulatory pathways for medical devices, in vitro diagnostics (IVDs), software-enabled products, combination products, and companion diagnostics (CDx).

The company claims proprietary technology platforms that enable a 50% efficiency gain in service delivery, alongside SMART Solutions, a life cycle partnership model launched in 2026. Service delivery is offered through three flexible partnering models: Outsourcing (full-service project delivery), Consulting (targeted outcome-focused expertise), and Staff Augmentation (on-demand MedTech talent). The firmographic record indicates 501-1000 employees with operational headquarters in Cary, North Carolina (US) and a regional headquarters in Altrincham, UK, with regulatory submission activity spanning the US, Europe, and UK.

Revenue is generated through professional services engagements, including project-based consulting contracts, multi-year outsourcing agreements, and staff augmentation deployments. The customer base includes 19 of the top 20 global medical device companies and 7 of the top 10 IVD companies, indicating enterprise-level penetration. Certifications include BSI ISO 9001 (certificate FS 565132) and RAPS Premium Solutions Partner designation. Note: the available input data contains internal inconsistencies (e.g., a $190,899 seed round from SFC Capital in March 2024 alongside a 501-1000 employee count), which limits confidence in certain financial inferences.

Name

Fern AI

Legal name

RQM+

Website

https://fern.ai

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Fern AI is a full-service MedTech CRO offering clinical evidence review, regulatory and quality consulting, clinical trials, lab services via Jordi Labs, and reimbursement strategy. It serves medical device and IVD companies, including 19 of the top 20 global medical device firms, across the US, Europe, and UK.

Ownership category

akta.pro rank

Product category

Clinical Evidence Review Platform

NAICS

Testing Laboratories and Services (541380), Management Consulting Services (54161), Other Scientific and Technical Consulting Services (541690), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical Trial Site Operations & Study Coordination (HLAGACAE)

akta.pro secondary industries

Stability Testing (ICH Programs) (HLAGADAD), Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Clinical evidence review
• Clinical research software
• Evidence synthesis
• Healthcare compliance
• Clinical trial management

Headquarters

HQ city

Monroeville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Revenue model

1. CRO Services: Full-service contract research organization offering regulatory & quality consulting, clinical trials management, lab & material science services, and reimbursement strategies. Revenue generated through project-based consulting engagements, outsourcing contracts, and staff augmentation services for MedTech companies.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Fern AI is a comprehensive platform for clinical evidence review that delivers quality and speed to market, while supporting compliance for organizations managing clinical research and evidence-based workflows.

Product overview

RQM+ is a full-service MedTech CRO offering a platform of four integrated service pillars: Regulatory & Quality, Clinical Trials, Lab & Material Science (via Jordi Labs), and Reimbursement. These services are delivered through three flexible partnering models: Outsourcing (full-service project delivery), Consulting (targeted expertise), and Staff Augmentation (talent on-demand). The company provides end-to-end support from concept through post-market for medical devices, in vitro diagnostics, software-enabled products, combination products, and companion diagnostics.

Differentiator

Problem solved

Functional benefit

Brands

• SMART Solutions: Life cycle partnership model for MedTech companies

Products and services

• Clinical Evidence Review Platform Comprehensive platform for clinical evidence review that delivers quality, speed to market, and supports compliance for clinical research and evidence-based workflows.

Quantifiable outcome

• 50% efficiency gain achieved through proprietary technology platforms
• +2 more outcomes

Named customers4 records

Segments6 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Medpace: Medpace is a mid-to-large CRO with growing MedTech and diagnostic device capabilities alongside its core small-molecule and biotech focus. It competes with RQM+ on clinical trial execution for device sponsors but does not emphasize the lab/chemical characterization pillar that Jordi Labs anchors.
• Eurofins Scientific: Eurofins is a global testing services conglomerate with extensive medical device and IVD testing capabilities, including chemical characterization and biocompatibility. It is a direct competitor to Jordi Labs and an indirect competitor to RQM+'s broader MedTech service portfolio.
• Parexel International: Parexel is a global CRO with regulatory consulting and clinical trial services that overlap with RQM+ in MedTech and combination product development. It serves many of the same large medical device OEMs that RQM+ counts as customers.
• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with expanding MedTech device testing services through its lab network. It competes with RQM+ in MedTech lab and regulatory support, particularly for clients seeking low-cost testing at global scale.
• ICON plc: ICON plc is a global CRO providing clinical, regulatory, and laboratory services across pharma, biotech, and MedTech. It overlaps with RQM+ in MedTech clinical trial operations and regulatory submissions, but operates at greater scale across therapeutic areas beyond MedTech.
• Charles River Laboratories: Charles River Laboratories provides laboratory services, CDMO capabilities, and research models across life sciences, including a meaningful MedTech-adjacent testing business. It competes with RQM+ on the Jordi Labs side (materials and analytical testing) rather than the regulatory consulting front.
• IQVIA: IQVIA is the largest global CRO, with significant MedTech clinical and regulatory capabilities as part of a broader pharma-biotech portfolio. It competes with RQM+ on large medical device and IVD engagements where scale and global reach matter, though it is not MedTech-specialized.
• Labcorp (Labcorp Drug Development): Labcorp provides central laboratory services and clinical development support with capabilities in diagnostics, biomarker testing, and IVD-adjacent workflows. It overlaps with RQM+ on clinical trial lab work and IVD-related testing services.

Emerging players

• Underwriters Laboratories (UL Solutions): UL Solutions provides medical device testing, certification, and regulatory advisory services with deep materials and safety testing expertise. It is a comparable peer to the Jordi Labs pillar of RQM+ and increasingly offers adjacent regulatory consulting for MedTech OEMs.

Direct peers

• NAMSA: NAMSA is the most direct MedTech-focused CRO peer, offering regulatory, clinical, and laboratory services specifically to medical device and IVD manufacturers. Like RQM+, it combines regulatory consulting with in-house lab testing and emphasizes full life-cycle support for MedTech clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/fern-ai

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

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 Fern AI