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QUALITY ASSURANCE

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Sion Medical Ltd. plants in Israel meet international standards and have certificates ISO 13485: 2016, ISO 9001: 2015, ISO 14001: 2015.

 

Our products have CE certificates, FDA registration and AMR certifications.

The quality division consists of several departments: Quality Assurance, Quality Control and Regulation.

1. Quality Assurance - This important function ensures that Sion products meet all the relevant requirements and standards. The role of the department is to ensure continuous control and improvement of Sion’s products.

2. Quality Control - Quality control is responsible for the initial inspection of the raw materials, for the inspection of the products during the manufacturing process and for the final inspection of the products before distribution, in which we confirm that our design and validation processes yielded products that meet our customers' needs. Quality control is not a substitute for creating processes that ensure a good product outside the production line, but it serves as a safety net in case a malfunction may occur.

3. Regulation - The role of the Regulatory Department (RA) is to ensure that our products meet the complex conditions and requirements set by the FDA, ISO, CE and other regulatory bodies. This area is responsible for obtaining marketing approval for our products and also provides assistance for our many partners.

To download quality assurance certificates

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