Medical Expertise

Quality

At the heart of our daily activities

SELENIUM MEDICAL is committed to a quality approach aimed at meeting the applicable regulatory requirements while satisfying the expectations of its customers, suppliers, employees and end users.

To structure and organise our services, we have set up a Quality system together with a quality policy and defined our quality reference systems. They are the fruit of a collective effort and serve to guide our day-to-day activities.

Our quality team works in line with a continual improvement approach which complies with the applicable regulatory requirements. It makes sure that all of the development, industrialisation and production stages are performed in compliance with internal procedures as well as customer and standard-related requirements.

Our quality policy

• Profiency with ISO13485 – ISO9001 – cGMP (FDA – 21CFRs) reference systems
• Validation of key stages in processes: design, inspection, manufacture, purchasing, etc.
• Industrialisation of products: project management and monitoring

 

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