ISO 13485 certification (https://iasiso-europe.com/french/iso-13485-certification-en-france/)provides a structured quality management framework for organizations involved in the medical device industry. It helps ensure that products are designed, manufactured, and delivered under controlled and documented processes. Certification supports compliance with applicable regulatory requirements while improving product quality, traceability, and risk management. It can also enhance customer confidence, reduce production-related issues, improve internal efficiency, and strengthen an organization's position in competitive medical device markets