Storage, CCAA And ISO 13485

Importers and / or conditioners of Medical Devices, Biomedical Equipment and In Vitro Diagnostic Reagents must have Certificate of Storage and Conditioning Capacity (CACA) issued by INVIMA. This certification is obtained after an inspection to the establishment (including facilities, equipment and processes) and audit to its Quality Management System.
The services we offer include: Design, implementation and maintenance of CCAA, Selection of Main Human Resources (Technical Director of the Importer), and facilities for the storage and / or conditioning process. We have a strategic alliance with storage companies located in Zona Franca, who have great experience in Logistics of Storage and Distribution of Health Products, and areas certified in BPM and CCAA.

We also offer design and implementation and audit services in ISO 13485 which is an adaptation of ISO 9001 for companies that produce and market medical devices and related services. The benefits that you as a customer can acquire through the implementation of this standard are: