Sonio Achieves ISO 13485 Certification for Medical Device Quality Management System

Sonio –  a leading provider of comprehensive solutions for pregnancy, maternal health, and child health, has achieved ISO 13485 certification for its medical device quality management system. The certification demonstrates our commitment to delivering efficient, secure solutions prioritizing quality and safety.

ISO 13485 is an internationally recognized standard for quality management systems for the medical device industry. The standard outlines the requirements for a comprehensive quality management system to ensure the safety and efficacy of medical devices. 

Achieving the ISO 13485 certification involved an extensive audit of our quality management system and manufacturing processes by an independent third-party (Notify Body). The certification process involved a detailed review of our documentation, processes, and procedures to ensure their effectiveness and compliance with the standard requirements.

To achieve the ISO 13485 certification, we underwent an extensive audit by an independent third-party certification body. The audit assessed the effectiveness of the company’s quality management system and evaluated its compliance with the ISO 13485 requirements.

“We are pleased to have achieved ISO 13485 certification, which serves as a testament to our team’s hard work and dedication to providing safe and effective solutions. This certification is an essential milestone that confirms our ability to meet the highest international standards for medical device design and manufacturing. Thanks a lot to the whole team, guided on this matter by Florian Akpakpa, our Head of Regulatory and Quality, for delivering so thoroughly while pushing further the boundaries of innovation in the field”

Cécile Brosset, CEO at Sonio

Since its foundation, Sonio is determined to develop innovative solutions for maternal and child health. The ISO 13485 certification is the latest in a series of achievements for us and our plans to continuously improve maternal and child health worldwide. The certification has positioned the company as a leader in the medical device industry and highlights its commitment to quality and safety.

With this certification, healthcare practitioners can trust that our solutions meet the highest standards for quality and safety in the medical device industry.