CE Marking

Ensure compliance of medical devices and in vitro diagnostic devices with EU requirements

Management Systems

Our medical device quality management system services, enhancing product quality and compliance.

Testing

Verify the quality and safety of your medical devices with our tests

Trainings

Medical device and in vitro diagnostic device training courses

CE Marking

CE certification opens the door to the European market, but it’s also a safeguard for your business, your partners, and end-users. With professional support from GCB, you ensure not just compliance, but also credibility, market trust, and protection from costly legal risks.

Audits

Our audits include an assessment of compliance with essential requirements, a fleet audit and a technical asset audit.

Training Programs

Introduction to Market

Ensure full compliance before placing machinery on the market. GCB provides expert support with CE marking, documentation, and conformity assessment to help you meet all EU regulatory requirements.

Management systems

Get ready with us for the certification of quality management systems in accordance with the guidelines: ISO 22716 and IFS HPC

Audits in the Cosmetics Industry - Compliance Assessment and Quality Supervision

Audits

Cosmetic Product Safety Assessment – CPSR Compliance with Regulation (EC) No 1223/2009

Safety Assessment

Product Life Cycle Assessment (LCA)

Life Cycle Assessment (LCA) is essential for optimizing environmental impact and building a sustainable business. Discover how LCA helps reduce emissions, resource consumption, and supports eco-certifications, strengthening your company’s market position!

Environmental Product Declaration (EPD)

An Environmental Product Declaration (EPD) is your key to transparency and building customer trust. Learn how EPD supports market requirements, boosts eco-certifications, and strengthens your company’s competitive edge!

ESG Training Programs

Curious about how ESG can transform your business? Explore GCB's training programs to learn how to implement sustainable practices, prepare ESG reports, and gain a competitive edge in the market!

European Sustainability Reporting Standards (ESRS)

Ensure compliance with ESRS and strengthen your company's position as a responsible business partner. With GCB's support, your ESG reports will be transparent, compliant, and effectively promote sustainable development.

Environmental Management System

Management systems in the sustainable environment sector are essential for regulatory compliance, process efficiency, and building a competitive edge. Discover how GCB can help you implement ISO 9001, ISO 14001, or ISO 45001 systems, supporting sustainabl

Medical Devices

MedTech industry includes diagnostic equipment, surgical instruments, implants, imaging devices, health IT systems, in vitro diagnostic medical devices and more.

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MedTech Industry

The medical device (MedTech) sector in the European Union encompasses a wide range of products and services aimed at improving patient care and quality of life. This includes diagnostic equipment, surgical instruments, implants, imaging systems, healthcare IT solutions, and in vitro diagnostics (IVDs). MedTech innovations support early diagnosis, minimally invasive procedures, and more effective therapies.

Types of Certified Medical Devices

Under EU regulations, certification covers medical devices (MD) and in vitro diagnostic devices (IVD). The process involves risk-based classification, preparation of technical documentation, and rigorous reviews and audits conducted by notified bodies.

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Services for the MedTech Industry

As a future EU Notified Body, we offer:

MDR and IVDR certification
Quality management system certification (ISO 13485)
MDSAP audits
Training and webinars
Organization of industry events

MedTech Industry

Bringing a medical device to the EU and global markets requires compliance with strict standards. Certification at GCB ensures:

Industry experience
Tailored approach
Highly qualified experts
Fast processing times
Comprehensive certification support
Modern tools and technologies

QMS certification ensures that organizations maintain top operational and design standards. At GCB, we offer:

Proven industry experience
Auditors with expertise and passion
End-to-end certification support
Up-to-date auditing methodologies
Efficient certification process
Minimal waiting time

Product testing allows for early detection of risks and evaluation of their impact on patient health. Our research services include:

Advanced laboratories
Experienced specialists
Detailed testing reports
Strong industry background
Customized approach
Investment in R&D

For low-risk products not requiring mandatory certification, we offer external verification to ensure regulatory compliance. Our verification process delivers:

Field-proven expertise
Highly qualified professionals
Comprehensive reporting
Independence and objectivity
Global quality standards

Training ensures personnel are well-prepared to meet regulatory requirements. Our training programs offer:

Interactive sessions
Instructors with real-world experience
Regularly updated materials
Customized content
Continual learning pathways

Medical industry events facilitate knowledge exchange and networking. GCB events offer:

Expert-led sessions
Top-tier industry specialists
Complete certification guidance
Modern tools and platforms
Personalized support

Our services

CE Marking for Medical Devices and IVDs

Ensure compliance of medical devices and in vitro diagnostic devices with EU requirements

Quality Management Systems in the Medical Device Sector

Our medical device quality management system services, enhancing product quality and compliance.

Medical Device Testing under MDR 2017/745 and IVDR 2017/746

Verify the quality and safety of your medical devices with our tests

Trainings

Medical device and in vitro diagnostic device training courses

Our Specializations

Our notified body, GCB, specializes in a wide range of certifications across various industries. With our experience and knowledge, we help companies worldwide ensure the highest quality and compliance of their products with EU and international market requirements.

Medical Devices

MedTech industry includes diagnostic equipment, surgical instruments, implants, imaging devices, health IT systems, in vitro diagnostic medical devices and more.

Find out more about medical devices

Medicinal Products

GCB supports pharmaceutical manufacturers through independent audits, documentation verification, and quality management system assessments. These services aim to confirm compliance with legal requirements and ensure the safety and efficacy of medicinal products introduced to the European and international markets.

Find out more about medicinal products