CERTIFICATIONS
CE MARKING
The Galénico Institute has the CE marking of its medical devices, ensuring to all its customers, comply with European standards.
This certificate ensures the regular assessment and verification of the quality and safety of our devices, through a monitoring of microbiological properties, carried out by an independent laboratory.
ISO 9001
The Galénico Institute has its Management System and Good Manufacturing and Distribution Practices certified by the ISO 9001 standard in the activities of manufacturing and marketing galenic products, medical devices, cosmetics and biocides.
This certification was the culmination of a work whose most significant steps were:
- Context analysis
- Identification of processes, establishment of objectives and indicators.
- Elaboration of the Good Manufacturing and Distribution Practices Management Manual and other documentation
- Training of all employees
ISO 13485
The Galénico Institute has its Management System and Good Manufacturing and Distribution Practices certified by the ISO 13485 standard in the activities of manufacturing and marketing galenic products, medical devices, cosmetics and biocides.
With this certification we intend to demonstrate compliance with Portuguese and European legislation in all of our activity.
