ISO 9001:2015

 

Elixir Surgical has implemented quality management system, which has been certified to ISO 9001:2015. This certification ensures that the company constantly delivers products that meet all customers’ needs and regulatory requirements and requires that we commit to the improvement of the system and ongoing conformity to regulations.

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The system has been audited by UKAS and subjected to successful surveillance audits to ensure ongoing compliance.

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ISO 13485:2016

 

We are proud to have achieved recognition as a company certified to the ISO 13485 medical device manufacturing standard.

 

The highlights of ISO 13485 requirements are:

- Promotion and awareness of regulatory requirements as a management responsibility.
- Controls in the work environment to ensure product safety.
- Focus on risk management activities and design control activities during product development.
- Specific requirements for inspection and traceability for medical devices.
- Specific requirements for documentation and validation of processes for medical devices.
- Specific requirements for verification of the effectiveness of corrective and preventive actions.