Plastod considers strategic to set up its organization basing it on the norms ruling the UNI EN ISO 9001:2015 Quality Assurance Systems and in particular the norm UNI EN ISO 13485:2016 which regulates the medical field. For such aim, it has a Company Management System which, in compliance with the Laws and prescriptions of "good manufacturing", grants first-class products free from risks to the final user.
In order to ensure a constant and excellent quality, in conformity to the norms ruling the classification and CE marking of Medical Devices, the following checks are performed on a regular base:
- On materials, used in any production step: from the incoming raw materials to the coating of the various backings, from the converting into finished products to the final packaging.
- On the level of microbial and particle contamination detected in the working environment and in the production equipments.
- On the correct identification of each batch produced, through the complete traceability in production and distribution cycles.
All risk classes
The accurate knowledge of the legislative and regulatory aspects allows Plastod to manufacture medical devices belonging to all classes indicated by the law in force, under its own responsibility.