Implementing and maintaining a strong Quality Management System (QMS) for your medical devices, products, and services lays a solid foundation for sustainable business growth. Achieving ISO 13485 certification demonstrates your organization’s commitment to meeting internationally recognized quality standards.
The certification process involves thorough on-site audits to evaluate the effectiveness and reliability of your QMS. Our experienced auditors review how well your system is applied in practice across design, development, manufacturing, and customer support.
As a trusted and globally accredited Notified Body, we offer services at regional and international locations. Our comprehensive portfolio is designed to provide tailored solutions that meet your specific operational needs and business objectives.
Benefits of ISO 13485 Certification
Ensures safe and effective medical devices, including Class I products
Enhances customer trust and confidence in your products and services
Helps meet international regulatory standards (MDR, IVDR, TCP, MDSAP)
Reduces risks of defective products, recalls, and compliance issues
Expands market access and product opportunities worldwide
Supports start-ups with a strong foundation for growth and expansion
Provides a framework to refine QMS processes, workflows, and operational efficiency
Facilitates seamless transition to specialized certifications
