Your trusted source for certification and conformity assessment
GCB – Global Certification Body Sp. z o.o. is a Polish certification body based in Warsaw, notified by the European Commission under number 3111 for conducting conformity assessments under Directive 2006/42/EC (Machinery). Our mission is to ensure transparent, reliable, and impartial conformity assessment and certification processes, enabling manufacturers and suppliers to place their products on the European Union market safely, effectively, and in full compliance with applicable legislation.
We operate as an independent Notified Body, providing comprehensive conformity assessments based on the highest technical, ethical, and regulatory standards. We specialize in the certification of medical devices, medicinal products, machinery, cosmetics, cybersecurity systems, and sustainability-related areas.
As a Notified Body (NB 3111), we are formally authorized to perform conformity assessments of machinery in accordance with Directive 2006/42/EC, as confirmed by the European Commission:
- Notified Body number: 3111
- Date of the latest notification decision: 24 July 2025
- Scope of notification: EC type-examination – Annex IX, Art. 12 (3)(b) and (4)(a)
Scope of GCB’s Activities
Our operations encompass a broad range of sectors that demand the highest level of compliance with European and international regulations:
We are currently in the process of notification as a Notified Body for conformity assessment of medical devices under Regulation (EU) 2017/745 (MDR). Our goal is to ensure a transparent, reliable, and impartial conformity assessment process in full compliance with the requirements of Regulation (EU) 2017/745.
GCB conducts independent verification of the quality and compliance of medicinal products with applicable EU standards — a key step for the effective and safe market authorization of the product.
As a Notified Body in the field of machinery (NB 3111), we are authorized to perform conformity assessments in accordance with the requirements of Directive 2006/42/EC. Our mission is to ensure the safe and compliant placement of machinery on the European Union market.
We certify the compliance of cosmetic products with safety and labeling requirements in accordance with Regulation (EC) No 1223/2009.
We assess and certify IT and IoT security systems in line with the latest EU requirements on data protection and digital resilience.
We provide environmental certification and assess corporate ESG compliance in line with the EU Green Deal and the Sustainable Development Goals (SDGs).
Impartiality
Impartiality in certification processes is a key factor ensuring the credibility and trustworthiness of issued certificates. This means that all activities and decisions undertaken by the certification body are entirely free from conflicts of interest, external influence, and bias, ensuring the objectivity and integrity of the conformity assessment process.
Impartiality is essential to ensure fair and reliable conformity assessment. It is the cornerstone of our credibility and legal compliance, enabling us to build long-term relationships with manufacturers based on professionalism and trust.
Certification decisions are made solely on the basis of objective evidence, in full compliance with ISO/IEC 17065.
An advisory body composed of stakeholder representatives oversees the absence of conflicts of interest and approves key procedures ensuring the impartiality of GCB activities.
We provide our clients with access to evaluation criteria, procedural rules, and appeal mechanisms, ensuring complete transparency of the certification process.
We Are Present on Every Continent
Our auditors and experts travel around the world, continuously verifying compliance of medical devices, medicinal products, machines, cosmetics, environment and cybersecurity, auditing manufacturing processes and building business relationships.
100%
We complete every assigned task with 100% commitment and see it through to the very end.
50+
50+ Our team already consists of dozens of experts with documented qualifications and undeniable experience. Their number is constantly growing.
2 mln+
We have analyzed at least this many documents, working on the certification of thousands of products entering the European Union market and international markets.
Team
Behind GCB stands a team of experienced experts from the regulatory, technical, and scientific sectors. We combine competencies gained in international certification bodies, research laboratories, and supervisory authorities. Our approach is built on integrity, up-to-date expertise, and complete transparency at every stage of the certification process.
Adam Sobantka
President of the Board
Chang Hoon Shin
Vice President
Karolina Skołucka-Szary
Director of Medical Devices Certification
Marta Zbucka-Gargas
Director of Sustainability
Kamil Zjawiony
Director of Machines Certification
Katarzyna Sobantka-Góralczyk
Chief Operating Officer
Ewelina Korycińska
Director of Quality Assurance
Katarzyna Suwik
Manager of medical devices certification for in vitro diagnostics
Tomasz Stępień
Machine Certification Manager
Wojciech Hercka
Quality Manager
Katarzyna Sroka
Acting Training Manager
Olga Suligowska-Gniady
Quality Manager
Joanna Czerepko
Senior Sustainability Expert
Karolina Stypułkowska
Biological Expert
Agnieszka Czajkowska
Clinical Technical Expert
Olga Zielińska
Lawyer
Agata Gmyrek
Specialist of HR, administration and financial settlements
Supervisory Board
Strategic oversight of GCB’s operations is exercised by an independent supervisory board, responsible for ensuring compliance with the principles of ethics, impartiality, and independence of the notified body.
Hyun Cheol Kim
Chairman of the Supervisory Board
Seung Ho Jung
Supervisory Board Member
Maciej Suwik
Supervisory Board Member
Tymon Zastrzeżyński
Supervisory Board Member
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