Quality Management
Quality at every Step.
Responsibility Throughout.
Our commitment to quality, safety and reliability spans the entire product life cycle.
Quality at every Step.
Quality Management
We take responsibility for the development, manufacture, and placing on the market of our medical devices.
This commitment is driven by consistent compliance with regulatory requirements and by a quality-, safety-, and risk-based approach throughout the entire product life cycle.
Our focus is on the continuous, systematic, and measurable improvement of product quality, process reliability, and the performance of our services through a risk-based quality management approach.
wide.
Quality Standards
Regulatory Requirements
Our process-oriented Quality Management System ensures compliance with applicable national, European and international legal, regulatory and normative requirements.
Processes & Responsibilities
Our Quality Management department continuously monitors, evaluates and documents process effectiveness. Standardized procedures and clearly defined responsibilities support consistent implementation across all business functions and manufacturing sites.
Suppliers & Service Providers
Structured monitoring ensures that supplied materials, components and services consistently meet defined requirements and specifications.
Certificates, Product Registrations and Import Licenses
Quality Management System
Our Quality Management System is certified in accordance with ISO 13485:2021 and complies with the requirements of the European Medical Device Regulation (MDR).
CE Marking
The CE marking confirms that our products comply with the applicable European requirements for safety, health protection, and performance. Before being placed on the market, our products are assessed and evaluated in accordance with the relevant legal and regulatory requirements.
The CE marking demonstrates compliance with applicable EU directives and regulations and enables the free movement of products within the European Economic Area (EEA).
International Market Access
For the respective target markets, we comply with all applicable regulatory requirements, including the necessary product registrations and import licenses.
Our Medi-Globe Network
Global presence.
Local Commitment.
Trusted by helthcare professionals in
over 120 countries.
120 +
countries
25 +
years of
experience
500 +
dedicated
employees