Quality Management System

The below QMS protocols and systems collectively form an integral part of Euromedix Healthcare’s commitment to maintaining high-quality standards and ensuring the safety and effectiveness of its medical devices throughout their lifecycle.

SO 13485 Compliance: Euromedix adheres strictly to ISO 13485 standards, ensuring that its QMS for medical device manufacturing meets international regulatory requirements.

Documented Procedures: The company maintains comprehensive documented procedures for all stages of manufacturing, including design controls, production processes, quality control, and post-market surveillance.

Risk Management: Euromedix implements a robust risk management system in line with ISO 14971, identifying, assessing, and mitigating risks associated with the design, production, and use.

Supplier Quality Management: A stringent supplier QMS is in place, ensuring that all raw materials and components sourced meet specified quality standards and comply with regulatory requirements.

Quality Control and Assurance: Rigorous quality control measures are employed throughout the manufacturing process, encompassing inspections, testing, and validation protocols to maintain product quality and consistency.

Training and Competency: Euromedix emphasizes continuous training and competency assessments for its personnel involved in manufacturing processes.

Traceability and Record-Keeping: A meticulous system for traceability and record-keeping is maintained, enabling the tracking of materials, components, and processes used in manufacturing, ensuring accountability and transparency.

Corrective And Preventive Actions: An established CAPA system is implemented to address any deviations, non-conformities, or complaints, taking corrective actions and implementing preventive measures to avoid recurrence.

Product Lifecycle Management: Euromedix manages the entire product lifecycle, from design and development through manufacturing to post-market surveillance, ensuring ongoing compliance and continuous improvement.

Regulatory Compliance and Audits: Regular audits and assessments are conducted to ensure compliance with regulatory requirements. The company maintains a proactive approach to regulatory changes, adapting its systems accordingly.