Sterifil renews ISO 13485 certification for medical devices
Sterifil has renewed its NM ISO 13485:2016 certification, reinforcing its quality management framework for medical devices. The certification is now valid until July 16, 2029.
The ISO 13485 standard sets specific quality management requirements for organizations involved in the medical device sector. Its renewal confirms the continuation of the systems implemented by Sterifil to address quality, safety, regulatory compliance and continuous improvement.
The certification covers a company operating across several stages of the medical device supply chain. Sterifil imports and distributes medical devices and also carries out manufacturing activities.
Its operations also include the sterilization of medical equipment and the assembly of medical kits. These activities require controlled processes and quality procedures designed to meet the requirements applicable to the sector.
The renewed certification provides a framework for Sterifil to continue its operations through 2029 while maintaining its quality management system. The company highlights process control and compliance with applicable quality standards as key elements of its approach.
The renewal also reflects the importance of recognized quality systems in the medical device industry, where regulatory compliance and process control form part of the requirements governing the production, handling and distribution of medical solutions.
Sterifil said it intends to pursue the development of its activities while maintaining compliance with the standards applicable to its operations.
