Take care of yourself with Identités !
We are pleased to announce that IDENTITES has obtained ISO 13485:2016 certification, recognizing the quality and safety of our medical devices.
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.
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.
Click on the button below to download our certificate.
Designed by starline, gstudioimagen and vectorjuice / Freepik and Freepik.
For more than 15 years, Identités has been offering solutions to improve the comfort and independence of the elderly and disabled.
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