What Qarad does

Qarad is a Belgium-headquartered regulatory consulting firm founded in 1986 that helps in vitro diagnostic (IVD) and medical device (MD) manufacturers achieve and maintain European market access under IVDR 2017/746 and MDR 2017/745. Its service portfolio spans CE Marking consulting, Quality Management System implementation, risk management, technical documentation, Performance Studies (Scientific Validity Reports, analytical and clinical performance studies), EU Authorized Representative services, PRRC staffing, medical writing, and a proprietary eIFU platform branded IFUcare (ifucare.io). The firm operates through legal entities in Belgium (Wilrijk headquarters, Geel registered seat), the United Kingdom, Switzerland, and Italy, and holds ISO 13485:2016 and ISO 27001:2022 certifications relevant to medical device quality systems and information security.

Commercially, Qarad generates revenue through professional services engagements (project-based and retainer), authorized representative retainers tied to non-EU manufacturers' regulatory filings, and managed SaaS subscriptions for the IFUcare eIFU distribution platform. Go-to-market is B2B sales-led, supported by thought-leadership channels including a regulatory newsletter, content marketing on IVDR/MDR topics, the Qarad Academy training program, MEDICA trade fair presence, and the annual QbD Conference. Founder Dirk Stynen serves as President, with Maurizio Suppo as Co-Founder and Vice President.

Qarad is a member of QbD Group, a multinational life sciences services organization with 650+ employees covering regulatory affairs, clinical, qualification & validation, quality assurance, lab services, toxicology, software solutions, and vigilance. Within this group, Qarad acts as the IVD and MD regulatory center of excellence, drawing on the broader group's resources for cross-functional engagements while operating its own customer-facing brand. Named clients include four of the Top 10 global IVD companies, nine enterprise customers outsourcing Scientific Validity Reports, and 50+ manufacturers using IFUcare.

Name

Qarad

Legal name

Qarad BV

Website

https://qarad.com

Company type

Private

Founded year

1986

Operating status

Operating

Headcount range

1–10 employees

Short description

Qarad is a Belgium-based regulatory consulting firm, part of QbD Group, that helps IVD and medical device manufacturers achieve CE marking and comply with EU IVDR and MDR through consulting, performance studies, EU Authorized Representative services, and its IFUcare eIFU platform.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Management Consulting Services (8742), Services-Testing Laboratories (8734)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industries

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Quality Management Systems (QMS) & ISO Training (ISO 9001/IATF/AS9100) (EDABAKAD)

Keywords

• Regulatory affairs consulting
• IVD regulatory compliance
• Medical device compliance
• CE marking services
• Performance evaluation studies

Headquarters

HQ city

Geel

HQ country

Belgium

HQ region

Europe

Offices6 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 Consulting Services: Professional consulting services including CE Marking, Quality Systems, Risk Management, Technical Documentation compilation and review, and regulatory strategy advisory services for IVD and MD manufacturers
2. Performance Studies: Clinical and analytical performance studies for IVD products, including scientific validity reports, organized in collaboration with Europe's renowned evaluation centers and blood banks
3. Representative Services: EU Authorized Representative services including CE Marking, Technical Documentation, and Risk Management for non-EU manufacturers
4. Training Services: Qarad Academy training programs, in-house training sessions, and ready-to-use tools and templates for regulatory compliance
5. E-Labeling/eIFU Services: Electronic Instructions for Use distribution platform (IFUcare.io) enabling manufacturers to digitalize paper IFUs and improve operational efficiency

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Qarad is a regulatory affairs consulting firm specializing in In Vitro Diagnostics (IVD) and Medical Device (MD) compliance for the European market. The company helps manufacturers achieve CE marking and maintain compliance under IVDR 2017/746 and MDR 2017/745 through consulting, performance studies, authorized representative services, PRRC staffing, medical writing, training, and a web-based eIFU distribution platform (IFUcare).

Product overview

Qarad is a regulatory consulting services company specializing in In Vitro Diagnostics (IVD) regulatory affairs. The company offers a comprehensive suite of services including Consulting (CE Marking, Quality Systems, Risk Management, Technical Documentation), Performance Studies (Scientific Validity Reports, Clinical and Analytical Performance Studies), E-Labeling/eIFU services through IFUcare, EU Authorized Representative services, Training programs (Qarad Academy and in-house), Medical Writing, PRRC services, and a Library of IVD and MD documents. As part of the QbD Group, Qarad provides regulatory expertise to help manufacturers achieve and maintain compliance with European IVDR and MDR regulations.

Differentiator

Problem solved

Functional benefit

Brands

• IFUcare: E-labeling/eIFU services platform for medical devices and IVDs, providing digital instructions for use solutions
• Qarad Academy

Products and services

• Consulting Services Regulatory consulting covering CE Marking, Quality Systems implementation (ISO 13485), Risk Management (ISO 14971), and Technical Documentation review and compilation for IVD and MD manufacturers targeting European market access.
• IFUcare (E-Labeling/eIFU) Web-based electronic Instructions for Use (eIFU) distribution platform enabling IVD and MD manufacturers to digitalize paper IFUs and reduce manufacturing, printing, and labor costs while maintaining EU and FDA compliance.
• Performance Studies Clinical and analytical performance studies for IVD products, including Scientific Validity Reports, Analytical Performance Reports, and Clinical Performance Reports compliant with EU IVDR 2017/746, organized in collaboration with European evaluation centers and blood banks.
• EU Authorized Representative Services EU Authorized Representative services for non-EU IVD and MD manufacturers, including CE Marking support, Technical Documentation maintenance, and Risk Management oversight to enable European market access without a physical EU presence.
• Training Services (Qarad Academy) Regulatory training programs including the Qarad Academy curriculum, in-house corporate training, and ready-to-use tools and templates for IVD and MD regulatory compliance.
• Medical Writing Services Documentation writing services for IVD Technical Documentation, Post-Market Surveillance reports, and Performance Study Documentation for IVD and MD manufacturers.
• PRRC Services Person Responsible for Regulatory Compliance (PRRC) staffing and oversight services for IVD and MD manufacturers requiring a qualified regulatory compliance officer under IVDR and MDR.

Quantifiable outcome

• Over 100 Scientific Validity Reports written for diverse markets
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• QbD GroupcoreOthersQarad is a member of QbD Group, a multinational organization supporting life science companies worldwide throughout the entire product lifecycle from idea to patient. Together they offer services in regulatory affairs, clinical, qualification & validation, quality assurance, lab services, toxicology, software solutions and services, and vigilance.

Scale indicators7 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• RQM+ (Resolian): Medical device and IVD regulatory and quality consulting firm offering services spanning CE marking, technical documentation, clinical evaluation, and quality systems. Direct competitor to Qarad in the IVD/MD regulatory consulting niche with similar customer profiles.
• ProPharma Group: Provides regulatory affairs, quality compliance, and clinical research services to pharmaceutical, medical device, and IVD manufacturers. Comparable in offering end-to-end regulatory consulting and quality system implementation to mid-sized and enterprise manufacturers.
• NAMSA: Medical device-focused contract research organization providing regulatory, clinical, and laboratory testing services for medical device and IVD manufacturers. Overlaps directly with Qarad on performance studies, regulatory strategy, and EU market access support.

Broad incumbents

• ICON plc: Global CRO with regulatory and clinical capabilities serving medical device and diagnostic sponsors. A larger incumbent offering integrated regulatory and clinical services, often competing for the same enterprise IVD/MD engagements as Qarad.
• IQVIA: Diversified life sciences services firm with regulatory affairs, quality compliance, and clinical evidence offerings for medical device and IVD manufacturers. Competes with Qarad for enterprise regulatory outsourcing contracts at the high end of the market.
• Charles River Laboratories: Major CRO providing regulatory, safety, and laboratory services to medical device and IVD clients. Comparable in offering end-to-end product lifecycle support, though at much larger scale and broader scope than Qarad.
• TÜV SÜD: Global Notified Body and conformity assessment organization active in CE marking for IVD and medical devices. While operating as a certification body rather than a consultant, it competes for client mindshare and adjacent services in the same European regulatory pathway.
• BSI Group: Major Notified Body issuing CE certificates under IVDR and MDR. Competes with Qarad indirectly as both organizations sit on the critical path for European market access, and BSI's expanded consultancy offerings overlap with Qarad's regulatory services.

Others

• QbD Group: Parent organization of Qarad; multinational life sciences consulting group offering regulatory, clinical, QA, qualification & validation, and software services. Included as an ecosystem participant that both supports and overlaps with Qarad's service portfolio.

Emerging players

• Freyr Solutions: Regulatory affairs and compliance services firm for medical devices, IVDs, and combination products. Comparable emerging peer with similar end-to-end regulatory and quality service offerings targeted at manufacturers seeking European market access.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/qarad

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Qarad