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Certifications

The whole manufacturing process at Silimed is in strict compliance with national and international standards of quality. Regularly audited by several agencies, the company always conforms with the certifications which it has won.

• Registration of all the products at the Brazilian Ministry of Health;

• Certificate of Good Manufacturing Practices granted by the National Agency for Sanitary Vigilance (Anvisa);

• ISO 9001 Certificate of Quality (International Organization for Standardization) granted by the German company MDC (Medical Devices Certification);

• ISO 13485 Certificate of Quality granted by the MDC;

• CE mark approved by the MDC; seal that gives products quality assurance in specific terms of the industry for medical or health products in general for the entire area of the European Community;

• GMP quality system (Good Manufacturing Practices of Medical Products) approved by the FDA (Food and Drug Administration), the North-American agency that controls food, medicine and medical material;

• Raw materials of North-American origin, duly registered at the FDA.