ISO 13485: The Quality Standard for Medical Devices
Quality is a critical issue for the medical device industry. Check out our toolkit to implement a management system and effectively manage risks in your company or laboratory.
Your needs
Do you work in the medical device (MD) sector in a role that involves addressing quality, compliance, and risk management issues? We’re offering you access to our toolkit.
Apply for ISO 13485 certification
Reassure your customers and clients by displaying a recognized sign of quality.
Become an ISO 13485 Auditor
Build credibility as a quality management systems auditor.
Training in medical devices
AFNOR Compétences offers a wide range of quality training courses.
The implementation of a quality management system specific to medical devices.
In the medical device sector, quality is not merely an organizational issue: it directly impacts patient safety, regulatory compliance, and risk management. Faced with the requirements of European Regulation 2017/745 and the challenges posed by new applications, such as AI or connected devices, manufacturers must be able to demonstrate the robustness of their quality management system. In this regard, the ISO 13485 standard serves as an essential framework for structuring, managing, and demonstrating this approach.
AFNOR helps you define your needs
Why implement a quality management system?
Patient safety and satisfaction, the use of AI in devices and software, and new care pathways are all challenges facing players in the medical device industry. Breast implants, catheters, implants, drug treatments… Recent history shows that defective products or services can have disastrous consequences. Industry professionals must therefore be beyond reproach in terms of quality management and risk control, and be able to prove it. On the regulatory front, Regulation (EU) 2017/745 imposes a number of safety and performance requirements on manufacturers. On the standards front, ISO 13485 is an essential tool.
