Qserve
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.
- Company typePrivate
- Founded1998
- HeadquartersArnhem, Netherlands
- Headcount1–10
- GTM typeB2B
- OfferingServices
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.
Qserve firmographics
Firmographics- Name
- Qserve
- Legal name
- Qserve Group BV
- Website
- https://qservegroup.com
- Company type
- Private
- Founded year
- 1998
- Operating status
- Operating
- Headcount range
- 1–10 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
Qserve industry classification
Industry- 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 primary industry
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)
- akta.pro secondary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
Keywords
Where Qserve is headquartered
LocationHeadquarters
- HQ city
- Arnhem
- HQ country
- Netherlands
- HQ region
- Europe
Offices7 records
Markets served
Qserve business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Regulatory Affairs Consulting: Consulting services for regulatory strategy, dossier submission support, global market access, and interim RA/QA support for medical devices and IVDs
- Clinical Research Organization (CRO) Services: Full-scope clinical trial management, PMCF studies, IVD performance studies, and clinical registries supporting market authorization
- Training Services: Online training modules, in-company training, virtual training, and on-demand webinars through Qserve Learn platform
- 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
Qserve product offering
Product offeringCore 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
Companies that use Qserve
Customer profileNamed customers10 records
Segments6 records
Ideal customer profiles5 records
Qserve technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability7 records
Feature4 records
Qserve partnerships and signals
Strategic signalScale indicators10 records
Recent moves7 records
Expansion highlights5 records
Qserve competitors and assessment
Company assessmentBroad 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
Qserve social profiles
Digital presenceQserve compliance and trust
Trust signalCompliance1 record
Qserve financial estimates
Financial estimateRevenue estimate
Valuation estimate
Qserve leadership team
Management profileNumber of profiles
Profiles8 records
Qserve funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Qserve M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Qserve
What does Qserve do?
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.
Is Qserve a public or private company?
Qserve is a private company. It is classified as management employee owned and is currently operating.
When was Qserve founded?
Qserve was founded in 1998. It employs 1 to 10 people.
Where is Qserve based?
Qserve is headquartered in Arnhem, Netherlands, in the Europe region.
How does Qserve make money?
Four revenue lines are on record. Regulatory Affairs Consulting is the primary driver. The others are clinical Research Organization (CRO) Services, training Services and EUDAMED Registration Services.
Who are Qserve's main competitors?
Broad incumbents on record are Medpace, IQVIA, ICON plc, TÜV SÜD, NSF International, Charles River Laboratories and BSI Group. Direct peers are NAMSA, Emergo by UL and RQM+ (now part of Resolian).
Does Qserve have an API?
No public API is recorded for Qserve.
What industry is Qserve in?
Qserve's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation, with a secondary code of HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight). Its NAICS code is 54169 and its SIC code is 8000.