Press Release – Villeneuve d’Ascq, March 18, 2025

Hemerion Therapeutics Achieves ISO 13485 Certification for Medical Device Quality Management System

Hemerion Therapeutics is a French healthtech start-up focused on developing innovative therapies for cancer. Its solutions combine small molecules and an illumination platform used during surgical tumor resection.The company has been awarded the ISO 13485:2016 certification for its Medical Device Quality Management System by the British Standard Institute (BSI).

This internationally recognized standard demonstrates the company’s commitment to maintaining a robust quality management system for the design, development, production, and distribution of its photonic medical devices.

The ISO 13485 certification signifies that Hemerion Therapeutics has implemented and maintains a comprehensive quality management system that meets the stringent requirements of the medical device industry. This achievement underscores the company’s dedication to ensuring the safety, efficacy, and regulatory compliance of its therapeutic platform.

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“Achieving ISO 13485 certification is a significant milestone for our young company, It reflects our unwavering commitment to quality and our ongoing efforts to provide healthcare professionals and patients with safe and effective medical devices. We are proud of our team’s hard work and dedication in achieving this important certification.“

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The ISO 13485:2016 standard is specifically designed for organizations involved in the medical device industry. It provides a framework for managing the quality of medical devices throughout their lifecycle, from design and development to production, installation, and servicing. By achieving this certification, Hemerion Therapeutics demonstrates its ability to consistently meet customer and regulatory requirements.

With this certification, Hemerion Therapeutics opens the door to international development of its technology.