What Certification Experts does

Certification Experts B.V. is a Netherlands-based regulatory compliance consulting firm founded in 1995 and headquartered in Breukelen, operating as the Product Compliance business unit within Kader Group B.V. The firm guides manufacturers of medical devices, machinery, electronics, and general products through CE marking, UKCA marking, EU MDR/IVDR compliance, Authorized Representation (EU AR, UKRP, EC REP, CH-REP), and Quality Management System implementation (ISO 13485, ISO 9001, GDP). Its proprietary Safexpert software supports CE marking and risk assessment workflows aligned with ISO 12100, the Machinery Directive, and the Low Voltage Directive.

The business is primarily professional services with a recurring software element via Safexpert. Pricing is quote-based with multi-year contract cadences, 60% advance payment, and 30-day invoice terms. Go-to-market combines a sales-led, consultative model with content marketing, SEO, and case-study-driven demand generation across Europe, the UK, the US, Canada, China, and Switzerland. In July 2024, the firm acquired CEpartner4U and its UK subsidiary UKCApartner4U, materially expanding Authorized Representative capacity and opening a Switzerland office. The customer base of 300+ spans enterprise names such as Airbus, Nestle, Siemens, and the Government of Canada alongside mid-market and startup clients across robotics, semiconductors, chemicals, and clean technology.

The firm maintains ISO 9001 and ISO 27001:2017 certifications (via Kader Group) and CO2 Prestatieladder Level 3, signalling quality, information security, and ESG positioning. With 11–50 employees, the firm competes as a specialized boutique against larger notified bodies and Big Four advisory practices, monetizing regulatory complexity through mandated Authorized Representation retainers, project-based CE/UKCA engagements, training, and Safexpert software licensing.

Name

Certification Experts

Legal name

Certification Experts B.V.

Website

https://certification-experts.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

11–50 employees

Short description

Certification Experts is a Netherlands-based regulatory compliance consultancy guiding manufacturers through CE/UKCA marking, EU MDR/IVDR compliance, Authorized Representation, and QMS certification, serving 300+ clients with proprietary Safexpert software and serving as part of Kader Group.

Ownership category

akta.pro rank

Product category

Regulatory Compliance Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Management, Scientific, and Technical Consulting Services (5416), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Engineering, Accounting, Research, Management (8700), Services-Engineering Services (8711), Services-Educational Services (8200)

akta.pro primary industry

Pre-Assessment, Gap Assessment & Certification Readiness Services (AFALACAE)

akta.pro secondary industry

Standards, Metrology & Accreditation Bodies (BPAIAOAC)

Keywords

• Regulatory compliance consulting
• CE marking services
• Medical device compliance
• Authorised representative services
• Quality management systems

Headquarters

HQ city

Breukelen

HQ country

Netherlands

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Compliance Consulting Services: Core revenue stream from providing regulatory compliance services including CE marking, UKCA marking, authorized representative services, technical file preparation, risk management, and regulatory compliance guidance for medical devices, machinery, electronics, and general products.
2. Quality Management System Services: Revenue from ISO 13485, ISO 9001 certification support, QMS implementation, internal audits, and GDP (Good Distribution Practice) license certification services.
3. Safexpert Software: Revenue from sale/licensing of Safexpert proprietary software for CE marking and risk assessment. The software includes modules for ISO 12100 compliance, workflow optimization, and team collaboration.
4. Training Services: Revenue from professional training programs including Quality Manager Training (ISO 13485), CE marking process training, and medical device training.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

Certification Experts is a consulting firm that delivers product compliance services end-to-end, including CE marking, UKCA marking, Authorised Representative (AR Experts) services, ISO 13485/ISO 9001 quality management system implementation, MDR/IVDR compliance, technical file preparation, risk management, and training. It also sells and licenses Safexpert, its proprietary CE marking and risk assessment software aligned with ISO 12100, Machinery Directive, and Low Voltage Directive.

Product overview

Certification Experts is a regulatory compliance consulting firm offering a comprehensive portfolio of product compliance and certification services. The core offering centers on Safexpert software for CE marking and risk assessment, supported by a broad range of consulting services including CE/UKCA marking, Authorized Representative services (under the AR Experts brand), Quality Management System implementation (ISO 13485, ISO 9001), and Medical Device Regulation (MDR/IVDR) compliance. The company operates as part of Kader Group and recently expanded through acquisition of CEpartner4U and UKCApartner4U to strengthen authorized representation capabilities across Europe, the UK, and Switzerland.

Differentiator

Problem solved

Functional benefit

Products and services

• Safexpert CE Marking & Risk Assessment Software Safexpert is Certification Experts' proprietary software for CE marking and Risk Assessment, aligned with the Machinery Directive and Low Voltage Directive. It provides modules for safety-centric project management, team collaboration, navigation of standards and EU directives, and ISO 12100 compliance. It is sold/licensed as a standalone product to manufacturers and compliance teams.
• CE Marking Services Comprehensive CE marking consulting services covering machinery and installations, electronics and electrical equipment, medical devices, ATEX 114 equipment, and general product safety. Engagements include risk assessment, technical file preparation, Declarations of Conformity, and EU market access support for manufacturers.
• UKCA Marking Services UKCA (UK Conformity Assessed) marking services for products entering the United Kingdom market post-Brexit, including conformity assessment, technical documentation, and UK market access support.
• Authorised Representative Services (AR Experts) Authorised Representative (AR Experts) services for non-EU/UK manufacturers, including EU Authorised Representative, EC REP for medical devices, UK Authorised Representative, UK Responsible Person (UKRP), Swiss Authorised Representative (CH-REP), GPSR Responsible Person, and Medical Device Registration services.
• Quality Management System (QMS) Services Quality Management System consulting and implementation, covering ISO 13485 (medical devices), ISO 9001, Article 10 of MDR, CAPA (Corrective and Preventive Actions), PRRC (Person Responsible for Regulatory Compliance), and GDP License / GDP certification for pharmaceutical and medical device supply chain compliance.
• Medical Device Regulation (MDR / IVDR) Compliance Services End-to-end services for EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR), including technical file preparation, clinical evaluations, EUDAMED registration, UDI assignment, MDSAP consulting, notified body coordination, and Declaration of Conformity.
• Training Services Professional training programs covering the CE marking process, medical device regulations, machinery safety, and quality management systems, including Quality Manager ISO 13485 training.

Quantifiable outcome

• Trusted by 300+ clients across multiple industries
• +1 more outcomes

Named customers22 records

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Five partnerships are on record, tiered core and minor.

• CEpartner4UcoreStrategic or Co-development Partner · 26 July 2024Certification Experts expanded its services through the acquisition of CEpartner4U and its subsidiary UKCApartner4U. This acquisition enhances the company's capacity to serve clients as Authorised Representatives in Europe, the UK, and Switzerland and broadens expertise in medical device compliance, including in-vitro diagnostic devices.
• UKCApartner4UcoreStrategic or Co-development Partner · 26 July 2024UKCApartner4U, a subsidiary of CEpartner4U, joined Certification Experts to strengthen authorized representation services for the UK market. This enhances the company's ability to support clients with UKCA marking and UK market access.
• Kader GroupcoreOthersCertification Experts B.V. is part of Kader Group B.V. The company operates under the Business Unit Consultancy & Interim, Product Compliance within the Kader Group structure.
• bol.comminorChannel Partner/ Reseller/ DistributorOfficial partner of bol.com, a major Dutch e-commerce marketplace.
• amazon.comminorChannel Partner/ Reseller/ DistributorOfficial partner of amazon.com, indicating marketplace distribution capabilities.

Scale indicators2 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• TÜV SÜD: Global testing, inspection, certification, and training giant. Directly comparable because it provides CE marking support, MDR/IVDR-related services, ISO 13485/9001 certification, and authorized representation services across medical devices and industrial products.
• TÜV Rheinland: Major notified body offering CE marking, machinery safety, EMC, ATEX, ISO 13485, and medical device regulatory services. Comparable as an end-to-end compliance partner to manufacturers across the same EU directives Certification Experts supports.
• DEKRA: Global testing and certification organization providing CE marking, product safety, EMC, ATEX, and QMS certification. Comparable because it serves overlapping machinery and electronics OEMs with similar regulatory compliance offerings.
• SGS: World's largest testing, inspection, and certification company. Comparable due to its extensive CE marking, ISO certification, medical device regulatory services, and global market access support that mirror Certification Experts' service lines.
• Bureau Veritas: Global TIC (testing, inspection, certification) firm offering CE marking, product compliance, ISO certification, and industry-specific compliance services. Comparable as a full-service alternative to Certification Experts for machinery and consumer product manufacturers.
• Intertek: Global quality assurance provider with CE marking, ATEX, EMC, and medical device regulatory services. Comparable because it supports manufacturers seeking EU market access through similar technical file preparation, testing, and certification services.
• BSI Group: UK-based standards and certification body with strong ISO 13485, ISO 9001, and medical device regulatory services. Comparable as a competitor in QMS certification and medical device compliance, particularly relevant for UKCA-adjacent work.

Direct peers

• MedEnvoy Global: Specialized Authorized Representative for non-EU/UK medical device manufacturers. Directly comparable as a niche AR provider offering EC REP, UKRP, and CH-REP services for medical devices and IVDs.
• Advena Ltd: UK-based Authorized Representative and PRRC service provider for medical devices. Directly comparable as a specialist in EU/UK medical device regulatory representation, mirroring Certification Experts' AR Experts offering.

Emerging players

• RQM+: Medical device regulatory and quality consulting firm offering MDR/IVDR consulting, clinical evaluation, and QMS services. Comparable as a specialized consulting peer focused on the medical device regulatory niche Certification Experts serves.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/cexperts

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Certification Experts