ISO 13485:2016 Certification

This certification reflects our commitment to providing you with products that meet the highest standards.

 

What is the purpose of ISO 13485:2016 certification ?

ISO 13485:2016 certification is an international standard that sets requirements for a quality management system (QMS) specific to the medical device industry. Here are its key features :

Ensuring the safety and performance of medical devices

It ensures that products meet regulatory requirements and customer expectations regarding quality, safety, and effectiveness.

Reducing product-related risks

The standard establishes rigorous processes for identifying and managing risks throughout the lifecycle of medical devices.

Improving regulatory compliance

It is recognized in many countries as an essential foundation for the registration of medical devices.

What are the main benefits for you as a customer ?

Quality assurance 

From design to production, distribution, and post-market monitoring, ensuring consistent quality at every stage.

Traceability 

The ability to trace the history, use, or location of products.

Risk management

Risks are better identified, analyzed, and mitigated at each stage of the product lifecycle.

Continuous improvement

A commitment to optimizing processes and products.

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