Richard Meester
CEO and Technical Consultant
- 9 years of experience
- Software
- Hardware and cybersecurity solutions
About us
We are a multidisciplinary quality and regulatory consulting firm, led by certified ISO Lead Auditors and QARA consultants, with over ten years of experience. Our mission is to help organizations achieve and maintain compliance in quality, safety, regulations and information security - in an efficient, transparent and measurable way.
Our expertise bridges engineering, regulation, management and information systems, allowing us to offer a unique 360° approach for certification, CE-marking and operational compliance. We work with manufacturers, start-ups and established companies in the medical, chemical, environmental and high-tech sectors in the Netherlands and the EU.
Our expertise
Quality Management Systems & Certification — We design, implement and optimize QMS and ISMS frameworks that comply with ISO 13485, ISO 9001, 14971, 15916, 22734, 22000, 27001 and many other standards and IEC standards.
Accelerated certification programs: from zero to fully certified according to ISO 9001 or 13485, with a proven, efficient methodology that saves time and resources.
Gap analysis and pre-audits: identifying critical QMS gaps before official inspections to ensure audit readiness and peace of mind.
Audit management and supplier audits: expertise in conducting internal audits and assessing suppliers (Supplier Management) according to ISO and FDA expectations.
Risk management and regulation: integrated approach that links quality and compliance activities to broader organizational processes.
Regulation, CE-marking & 510(k) submissions
We provide strategic Regulatory Affairs support for smooth CE-marking and US FDA 510(k) submissions.
End-to-end CE-marking: from conformity strategy to technical documentation, for a smooth and successful certification process.
Global market access: tailored regulatory strategies to accelerate product access to the EU and US market, with compliance to both MDR and FDA.
Operational and production-related compliance: ATEX, Machinery Directive, REACH and HACCP requirements for process, production and food processing, fully aligned with EU regulation.
Technical documentation & clinical evaluation
We support companies in the medical and life sciences sector in building technical files and clinical evaluation reports (CER) that meet the latest MDR and MEDDEV requirements.
MDR-compliant documentation: complete, audit-proof files that meet EU and international standards.
Clinical evidence for class I and IIa: generation of clinical data demonstrating safety and performance of medical devices and ensuring continuous market access.
Comprehensive compliance capabilities
In addition to quality and regulation, our consultants offer practical experience with:
ATEX and Machinery Directive compliance.
Chemical management, waste processing, REACH and environmental regulation.
Vehicle and industrial regulation in the Netherlands and the EU.
Information security & data protection: ISO/IEC 27001-2022, GDPR and NIS2 directive implementation.
This combination of technical depth and regulatory expertise enables us to provide integrated compliance solutions, from production and environmental security to data protection and cybersecurity.
Our approach
We believe compliance should be clear, practical and value-driven. Our team works closely with clients to translate complex standards into actionable processes that support certification, improve efficiency and drive continuous improvement.
Our goal is to be a long-term partner for your organization — from concept to certification or compliance — ensuring your systems not only meet standards, but are also robust, efficient and ready for growth.
Our consultants
Meet the people driving operational quality and continuous improvement at BNR Quality. Our experts combine years of industry experience with a shared mission: helping organizations achieve and maintain the highest quality standards.
Mhand Boulidam
QARA Director and Consultant
- 17 years of experience
- Medical devices, QMS/ISMS
- Regulatory advice
- Provides training
Firas A. Abdulkareem
QARA 'PhD' Advisor and Consultant
- 8 years of experience
- QMS/ISMS
- Technical implementations
- Regulatory advice
Bryan Meester
Marketing / Photo & Videographer
- 5 years of experience
- Strategic marketing & positioning
- Visual production (photo & video)
Marit Meijer
Marketing
- 3 years of experience
- Branding & positioning
- Content strategy
Quality-oriented experience and milestones
2008
ISO 13485 for medical devices and quality management systems (QMS)
ISO 14971 Risk Management
ISO 9001 and structural QMS for manufacturers and service providers
Information security – General requirements
2025
One Audit – Multiple Standards (Compliance aspect)
Regulatory-oriented experience and milestones
2009
Transition: from MDD to MDR-readiness
Entry to the US market: FDA 21 CFR Part 820 & 510(k)
HACCP and food processing
Machinery Directive and industrial regulation
Environmental and REACH regulation
2025
Information security, GDPR and NIS2 directives