Sion’s manufacturing facilities around the world operate by the strictest international standards and hold the following certifications: ISO 13485:2016, ISO 9001:2015, and ISO 14001:2015. The company’s products are certified under MDR-CE, FDA, and AMAR.

​

Sion’s Quality Division is composed of three central departments:

Regulatory Affairs (RA) – Ensures that products comply with the regulatory requirements of authorities such as the FDA, CE, ISO, and other global regulatory bodies. The department is responsible for obtaining marketing authorizations and also provides regulatory support to our business partners.

Quality Assurance (QA) – Responsible for ensuring that all products comply with regulatory requirements and relevant standards, with a strong emphasis on control processes and continuous improvement throughout all stages of development and production.

Quality Control (QC) – Conducts comprehensive testing of raw materials, products at various production stages, and final goods before distribution. This process ensures that design and validation result in high-quality products that meet customer needs. 

: View Our Certification