Qserve

What Qserve does

Qserve Group BV is a Netherlands-headquartered regulatory affairs and clinical research consultancy specializing exclusively in medical devices and in vitro diagnostics. Founded in 1998 in Arnhem, the firm serves Class I–III medical device manufacturers, IVD producers, combination-product developers, companion diagnostics partners, MedTech start-ups, and M&A investors across Europe, the United States, and China, with stated coverage of 80+ markets globally. Qserve is positioned as the largest EU consultancy 100% focused on medical devices and IVDs, combining traditional regulatory affairs, quality assurance, and notified-body engagement with in-house CRO capabilities.

The company's offering spans a full lifecycle service portfolio — regulatory strategy, dossier preparation, CE marking, FDA 510(k) submissions, global market access, QMS implementation, auditing, clinical investigation support, and M&A due diligence — delivered by a team of 55+ professionals with 500+ years of combined medical-device expertise. Two proprietary digital products layer onto the services base: Qserve InSight, a regulatory intelligence platform covering 80+ countries with integrated FDA-recognized and ISO standards content; and Qserve Learn, a subscription training platform with e-learning, virtual training, and on-demand webinars. EUDAMED-related XML bulk-upload and DI generator tooling, plus a 2026 AI/ML Regulatory Support service addressing GMLP and EU AI Act readiness, extend the technology surface. Certification to ISO 9001 (2024–2027) covers the underlying quality management system.

Qserve's revenue mechanics are anchored in professional services engagements sold through direct enterprise sales, quote-based project pricing with no public rate cards, and a smaller subscription/recurring stream from Qserve Learn training. Customer concentration is mixed between marquee MedTech and pharma enterprise accounts and a broader long tail of 824+ cumulative satisfied clients. The company is privately held with no disclosed external institutional funding, and the Board of Directors comprises the CEO, CCO, CSO, and COO alongside founder Willibrord Driessen.

Name

Qserve

Legal name

Qserve Group BV

Website

https://qservegroup.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

51–100 employees

Short description

Qserve Group BV is a Netherlands-based medical device and IVD regulatory affairs consultancy and CRO, founded in 1998, serving manufacturers globally with regulatory strategy, clinical research, quality assurance, EUDAMED submissions, and AI/ML compliance services across offices in Europe, the US, and China.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Custom Computer Programming Services (541511)

SIC

Services-Health Services (8000)

akta.pro industry

PRIMARYHLAGAKAD

Quality Management Systems (QMS) & GxP Documentation

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

SECONDARYHLAGAKAI

Clinical Quality Assurance (GCP QA, TMF/QMS oversight)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

Keywords

• Medical device consulting
• Regulatory affairs services
• Clinical research organization
• IVD compliance consulting
• EUDAMED submission services

Headquarters

HQ city

Arnhem

HQ country

Netherlands

HQ region

Europe

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs Consulting: Consulting services for regulatory strategy, dossier submission support, global market access, and interim RA/QA support for medical devices and IVDs
2. Clinical Research Organization (CRO) Services: Full-scope clinical trial management, PMCF studies, IVD performance studies, and clinical registries supporting market authorization
3. Training Services: Online training modules, in-company training, virtual training, and on-demand webinars through Qserve Learn platform
4. EUDAMED Registration Services: Device registration and UDI submission support using XML bulk upload methodology

Go-to-market motion1 record

Distribution channels1 record

Marketing channels8 records

Core offering

Qserve is a specialized consulting firm focused 100% on medical devices and in-vitro diagnostics (IVDs), offering regulatory affairs consulting, quality assurance services, clinical research (CRO) capabilities, and global market access support. The firm provides end-to-end support from regulatory strategy through market authorization across 80+ markets, complemented by the Qserve InSight regulatory intelligence platform and the Qserve Learn online training platform. Services include CE marking, FDA submissions, MDR/IVDR compliance, clinical investigations, EUDAMED device registration, and AI/ML regulatory support for medical device manufacturers globally.

Product overview

Qserve is a specialized medical device and IVD consultancy offering an integrated portfolio of regulatory affairs, quality assurance, clinical research (CRO), and training services. The company operates as both a traditional consultancy and a technology-enabled platform, with two primary digital products: Qserve InSight (regulatory intelligence platform automating tracking of updates across 80+ countries) and Qserve Learn (online training platform for MedTech professionals). The service portfolio includes regulatory affairs consultancy, quality assurance, clinical investigations, EUDAMED device submission services, AI/ML regulatory support, mergers & acquisitions due diligence, and global market access support. The company positions itself as a full-scope CRO combined with regulatory expertise, providing end-to-end support from early development through post-market surveillance.

Differentiator

Problem solved

Functional benefit

Brands

• Qserve Learn: Online training platform for MedTech and IVD professionals offering expert-led courses, virtual training, and on-demand resources.
• Qserve InSight
• Qserve MedTech Conference

Products and services

• Qserve InSight Regulatory intelligence platform that automates collection, filtering and organization of global regulatory updates across 80+ countries with FDA-recognized standards, CEN/CENELEC content and ISO standards coverage. Designed for medical device and IVD regulatory professionals.
• Qserve Learn Online training platform with expert-led courses, virtual training and on-demand resources for regulatory, quality and clinical professionals in medical device and IVD sectors. Covers e-learning modules, virtual training, and on-demand webinars.
• Clinical Research Services (CRO) Full-service Contract Research Organization providing end-to-end clinical investigation support from study design and execution to regulatory submissions, specifically designed for medical device and IVD trials. Includes PMCF studies, IVD performance studies, and clinical registries.
• Regulatory Affairs Consultancy Strategic guidance and support for regulatory compliance including dossier submission support, regulatory strategy, global market access and FDA consulting for medical devices and IVDs. Spans entire product lifecycle from development to post-market activities including CE marking and FDA submissions.
• Quality Assurance Services End-to-end Quality Assurance support including Quality Management System implementation, hands-on QA support, auditing services and CAPA management. Includes internal audits, supplier audits, mock audits and gap assessments for MDR, IVDR, MDSAP, QMSR and ISO 13485.
• Clinical Investigations Clinical investigation support covering strategy development, protocol writing, PMCF surveys and studies, IVD clinical performance studies, clinical trials and clinical registries for medical device and IVD manufacturers.
• EUDAMED Device Submission Service One-stop-shop EUDAMED submissions including structured UDI strategy, data validation, XML generation and bulk uploads for medical device registration in compliance with European Commission format specifications.
• AI/ML Regulatory Support Comprehensive AI/ML compliance services supporting medical device manufacturers through Good Machine Learning Practices (GMLP) implementation, QMS adaptation, EU AI Act readiness and technical documentation for notified body submissions involving AI-enabled devices.
• Mergers & Acquisitions Due Diligence Regulatory due diligence assessment for merger and acquisition processes, evaluating product portfolio compliance and quality management systems of target companies. Includes technical documentation review and regulatory risk identification.
• Global Market Access Global registration services and legal representation supporting market access for medical devices across 80+ markets worldwide, covering 500+ successful registrations.
• Interim Support Interim consultants providing flexible resourcing to temporarily fill Regulatory Affairs, Quality Assurance and Clinical roles to maintain compliance and keep critical projects moving for medical device manufacturers.
• In Vitro Diagnostics (IVD) Regulatory Consultancy IVD-specific regulatory support including EU IVDR conformity assessment, US FDA submissions, performance evaluation and technical documentation to IVDR Annex II and III for diagnostic manufacturers.
• Companion Diagnostics (CDx) Services Regulatory support for companion diagnostics and personalized medicine including alignment of pharma and IVD regulatory paths and biomarker clinical trials for pharmaceutical and diagnostic partners.

Quantifiable outcome

• 750+ successful MDR submissions
• +4 more outcomes

Named customers10 records

Segments6 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature4 records

Scale indicators10 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Medpace: Mid-sized CRO with a full-service clinical model and growing medical device practice; serves similar enterprise sponsors, although MedTech is a smaller portion of its primarily pharma-led book.
• IQVIA: Global CRO and life sciences services leader; serves many of the same medical device and pharma companies as Qserve through its broader clinical and regulatory portfolio, but MedTech is a smaller slice of a much larger franchise.
• ICON plc: Major global CRO and clinical research services provider that includes MedTech and IVD capabilities within a broader pharma-leaning portfolio; competes for the same large device manufacturer clients on clinical trial services.
• TÜV SÜD: Global notified body and testing/certification organization; competes with Qserve on regulatory strategy, EU MDR/IVDR assessment preparation, and quality system certifications from the testing/certification side of the market.
• NSF International: Global public health and safety organization with MedTech regulatory consulting, training, and ISO certification services overlapping with Qserve's QA and training businesses.
• Charles River Laboratories: Large life sciences research organization with growing MedTech/CDMO capabilities; offers regulatory and clinical services that overlap with Qserve, particularly for combination products and IVD sponsors.
• BSI Group: Notified body and standards organization with regulatory, training, and consulting offerings for medical device and IVD manufacturers; covers the same MDR/IVDR transition and quality system needs as Qserve.

Direct peers

• NAMSA: The world's largest MedTech-focused CRO offering regulatory, quality, and clinical services for medical device and IVD manufacturers; the most directly comparable service portfolio to Qserve, with similar exclusive focus on MedTech.
• Emergo by UL: Medical device and IVD regulatory consultancy under UL Solutions; provides global market access, EU MDR/IVDR consulting, and quality systems services directly comparable to Qserve's core offering.
• RQM+ (now part of Resolian): Specialized medical device and IVD regulatory and quality consulting firm, founded by ex-notified-body auditors; competes head-to-head with Qserve in MDR/IVDR consulting, QMS implementation, and clinical strategy for MedTech clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/qserve-group
• Xx.com/Qserve_Group

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Qserve