We are pleased to announce that Complife Group has significantly expanded and strengthened its integrated Quality Management System with the achievement of a new and highly strategic certification: EN ISO 13485:2016, the international standard specifically dedicated to Medical Devices.

The new ISO 13485 certification covers several legal entities of the Complife Group, located in different countries. This important milestone reinforces our ability to provide robust, controlled, and fully compliant processes across the entire Medical Device lifecycle.

What EN ISO 13485:2016 brings to our clients?

This new certification allows Complife Group to strengthen its positioning in the medical device sector by ensuring:
• Regulatory compliance – Alignment with stringent international requirements, supporting global market access;
• Operational efficiency – Streamlined and traceable processes that enhance productivity and reduce inefficiencies;
• Market access – Standardized compliance facilitating entry into worldwide markets and increasing competitive advantage;
• Risk management enhancement – Systematic methods to identify and mitigate risks across the product lifecycle, ensuring patient and user safety;
• Enhanced reputation – Greater trust and credibility with customers and end-users thanks to adherence to a globally recognized quality standard.

As a further confirmation of our continuous commitment to excellence, Complife Group has also renewed its ISO 9001:2015 certification for quality management on all its sites, including a first release for Complife Romania.

Complife can boast a single quality system for the entire group, that integrates multiple international standards: 

ISO 9001 — globally recognized standard for quality management;
ISO 13485  — quality management systems in the design and manufacture of medical devices;
ISO 21001 — international standard for Educational Organizations Management Systems (EOMS);
ISO 17025 — international standard for testing and calibration laboratories.

With these important achievements, Complife Group further strengthens its position as a trusted global partner in science-driven innovation.

As a further confirmation of our continuous commitment to excellence, Complife Group has also renewed its ISO 9001:2015 certification for quality management on all its sites, maintaining the highest quality standards across all service areas.

READ ALL THE CERTIFICATIONS

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