Pure Global

What Pure Global does

Pure Global, operating under the legal entity PureVision Ai, Inc. (with DBAs Pure Global and PureFDA), is a private medical device and in-vitro diagnostic (IVD) regulatory consulting firm founded in 2020 and headquartered in Jersey City, NJ. The firm serves medical device and IVD manufacturers ranging from startups to global scaleups and multinational enterprises, helping them navigate registration, local representation, and post-market compliance requirements across more than 30 countries spanning the Americas, Europe, the Middle East and Africa, and Asia Pacific. Its core service is bundled annual market access support, combining AI-powered dossier compilation, in-country representation, translation, distributor authorization, and post-market surveillance into a single flat-fee subscription starting at $2,000 USD per year per device, alongside specialized EU MDR and EU IVDR consulting practices and a clinical services offering with sites in the US, Europe, and Africa.

The company's technology backbone is GRIP (Global Regulatory Intelligence Platform), an AI- and data-powered research and workflow tool that aggregates global regulatory news, streamlines document search, and compares clinical and submission data across markets. Underlying capabilities include natural language processing of regulatory guidance and dossier content (including for AI-enabled medical devices under MDCG 2025-6), structured data analysis across jurisdictions, and process automation for dossier compilation that compresses document preparation timelines. The firm operates 15+ offices across five continents, giving it in-country presence in major medical device markets and enabling direct regulatory representation rather than partner-mediated submissions.

Commercially, Pure Global runs a hybrid go-to-market that combines enterprise field sales for multinational accounts, inside sales for mid-market, and a self-service fee calculator on its website for preliminary pricing discovery. Customer segments are horizontal by size tier (startups, global scaleups, multinational enterprise) and the firm reports 500+ clients served cumulatively and 2,500+ global registration certificates obtained on behalf of clients. Leadership consists of co-founder and COO DeJian Fang, CTO Ran Chen, and CBDO Michael Van Der Woude; no institutional investors, parent company, or funding rounds are disclosed in the available sources.

Name

Pure Global

Legal name

PureVision Ai, Inc.

Website

https://pureglobal.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

51–100 employees

Short description

Pure Global (PureVision Ai, Inc.) is a private medical device and IVD regulatory consulting firm that combines its AI-powered GRIP intelligence platform with local in-country representation across 30+ countries, serving startups, global scaleups, and multinational manufacturers via flat-fee annual subscriptions.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

All Other Professional, Scientific, and Technical Services (541990)

SIC

Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Medical device consulting
• Regulatory affairs services
• Global market access
• AI regulatory intelligence
• EU MDR compliance

Headquarters

HQ city

Jersey City

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Annual Registration Services Subscription: Pure Global operates on a flat-fee annual subscription model providing comprehensive medical device regulatory services including dossier submission, in-country representation, translation services, regulatory modifications, distributor authorization, and post-market support. The pricing starts at $2,000 USD per year for the first device, with government fees excluded.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Pure Global provides regulatory consulting and market access services for medical device and IVD manufacturers, bundling AI-powered dossier compilation, in-country regulatory representation across 30+ countries, translation, distributor authorization, and post-market support under a flat annual fee. Its proprietary GRIP platform aggregates global regulatory intelligence and streamlines compliance workflows, while the firm's local offices deliver hands-on registration and representation in key markets worldwide.

Product overview

Pure Global offers a unified platform combining AI-powered regulatory intelligence tools (GRIP) with comprehensive regulatory consulting services for medical device and IVD market access. The core offering spans market access services with local representation across 30+ countries, clinical services with sites in the US, Europe, and Africa, and specialized EU MDR/IVDR consulting. The company operates a flat-fee pricing model (starting at $2,000 USD/year) that bundles AI-powered dossier compilation with in-country representation, translation, and post-market support into a single annual subscription.

Differentiator

Problem solved

Functional benefit

Products and services

• GRIP (Global Regulatory Intelligence Platform) AI-powered regulatory intelligence platform that aggregates global regulatory news, streamlines document searches, and compares clinical data across 30+ markets to support medical device and IVD compliance. Used by manufacturers' regulatory teams to monitor evolving requirements and accelerate dossier preparation.
• Market Access Services Local representation and registration services across 30+ countries for medical device and IVD manufacturers, including dossier submission, in-country representation, translation services, regulatory modifications, distributor authorization, and post-market support, delivered through the firm's 15+ global offices.
• Clinical Services Clinical trial and study support services for medical device manufacturers, with clinical sites operating in the United States, Europe, and Africa. Provides clinical evidence development, evaluation, and study execution to support regulatory submissions across multiple jurisdictions.
• EU MDR Consulting Comprehensive EU Medical Device Regulation (MDR 2017/745) compliance support for medical device manufacturers, including classification, CE marking, clinical evaluation reports, post-market surveillance, EUDAMED registration, and authorized representation services.
• EU IVDR Consulting In Vitro Diagnostic Devices Regulation (EU 2017/746) compliance support for IVD manufacturers, including IVDR classification, CE marking for IVDs, performance evaluation reports, post-market performance follow-up, and authorized representation.
• Post-Market Surveillance (MDR & IVDR) Post-market surveillance planning and implementation for MDR and IVDR compliance, including PMS plans, PMS reports, periodic safety update reports (PSURs), and trend reporting to maintain ongoing regulatory compliance for medical device and IVD manufacturers.

Quantifiable outcome

• Dossier compilation time reduced significantly through AI-powered tools
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature3 records

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Greenlight Guru: Greenlight Guru provides quality management and regulatory affairs software purpose-built for medical devices, including document control, design history files, and submission workflows. Overlaps with Pure Global on AI-enabled regulatory workflow automation for medical device manufacturers, particularly mid-market and startup segments.
• Freyr Solutions: Freyr is a life sciences regulatory consulting and outsourcing firm offering regulatory affairs, pharmacovigilance, and technology-enabled compliance services for medical devices, pharma, and biotech. Direct overlap with Pure Global on medical device registration, global in-country representation, and AI-augmented dossier services across multiple markets.
• Rimsys: Rimsys is a software platform for medical device regulatory intelligence and submission management, offering AI-enabled tracking of global regulations, submission timelines, and standards. Direct competitor to Pure Global's GRIP platform and a potential substitute for the regulatory intelligence portion of Pure Global's bundled offering.

Broad incumbents

• Parexel International: Parexel is a global CRO with dedicated regulatory consulting and medical device practice areas. Competes with Pure Global on multi-market device registrations and clinical/regulatory strategies for multinational manufacturers, though Parexel's primary footprint is pharma/biotech clinical trials.
• IQVIA: IQVIA is the world's largest CRO with deep regulatory affairs capabilities, technology platforms (e.g., IQVIA RIM), and global delivery infrastructure. Competes with Pure Global on enterprise regulatory engagements, especially in pharma and medical device dossiers, though its scale and broader portfolio differentiate it from a focused med-device consultancy.
• ICON plc: ICON is a top-tier global CRO offering regulatory, clinical, and consulting services across pharma, biotech, and medical devices. While ICON serves a much broader life sciences portfolio and is significantly larger, its medical device regulatory consulting group competes head-on with Pure Global for multinational enterprise engagements.
• TÜV SÜD: TÜV SÜD is a global testing, inspection, certification, and training organization with notified-body designation for medical devices. Its medical device regulatory consulting, CE marking, and authorized representation services overlap with Pure Global's market access and EU MDR offerings, especially for multinational enterprise clients.
• Charles River Laboratories: Charles River provides preclinical, clinical, and regulatory consulting services with growing medical device exposure. Overlaps with Pure Global on regulatory consulting and clinical evidence generation, but operates primarily through lab-based and discovery services for broader life sciences clients.
• BSI Group: BSI is a notified body for medical devices under EU MDR/IVDR, also offering compliance consulting, CE marking, and standards services. While primarily a certification body, BSI's regulatory consulting practice competes for EU-focused device compliance engagements that overlap with Pure Global's EU MDR/IVDR consulting offering.

Emerging players

• NSF (formerly NSF Health Sciences): NSF provides regulatory consulting, training, and certification services for medical devices and pharma with growing technology-enabled compliance offerings. NSF's medical device regulatory practice competes with Pure Global on dossier preparation, training, and quality systems, though with a more consulting/education focus than Pure Global's bundled AI-plus-local-rep model.

Market position

Strengths5 records

Weaknesses2 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 Pure Global