- Quality management system according to:
- NF EN ISO 13485 : 2012
- ISO 9001 : 2008
- Directive 93/42/EEC, Annex V, Section 3
- ISO 11135-1 : 2007 for sterilization
- Application of the Tunisian GMP.
- Approval for manufacturing and control from the Tunisian Ministry of Health.
