ISO 13485 certification renewal: Strengthening the Foundations of Quality Excellence

Quality in the field of pharmaceutical-grade biopolymers is reinforced through controlled processes, systematic monitoring, and continuous improvement across all stages of development and manufacturing. This perspective guided the recent ISO 13485 recertification audit at HTL Biotechnology’s industrial site, an important milestone in maintaining the robustness of our quality management system.

A Structured Assessment of Our Quality System

On September 30th and October 1st, GMED auditors conducted the renewal audit of our ISO 13485 certification for Hyaluronic Acid and Polynucleotides. This audit reflects the year-round work involved in meeting rigorous regulatory requirements, while ensuring best practices in the field of medical devices.

This ISO 13485 recertification guarantees the quality of the design and manufacturing of our medical devices, ensuring full compliance with regulatory and client requirements in terms of safety and efficacy.

A Result Reflecting Operational Discipline

This year’s audit concluded with no non-conformities, highlighting:

• the strength and consistency of the quality system
• continuous improvement and commitment to excellence of all our teams.

Sustaining Quality as Operations Evolve

The renewal of the ISO 13485 certification is not only a quality requirement, but also a foundation for the trust placed in us by our partners. As new biopolymers and production capabilities are added to our portfolio, quality management remains central to these developments.

Future process improvements, expansions, and product innovations will continue to be integrated within the same structured quality framework, ensuring alignment with regulatory expectations and industry best practices.

Looking Ahead

The successful renewal of ISO 13485 reflects the collective work of our teams involved in maintaining controlled, compliant, and efficient operations. It also reinforces the principles that guide our approach to manufacturing: consistency, purity, and commitment to improving quality over time.

With this recertification, our quality foundations remain strong as we continue to support the development and production of biopolymers for tomorrow’s medical needs.

To find out more about our excellence in quality :

Excellence in Quality – HTL Biotechnology