It doesn’t matter which department you work in, what is important is that you acquire the basic knowledge of the quality management system based on the ISO 13485 standard.
It supports the obligation to ensure that products consistently meet applicable regulatory requirements for manufacturing, handling, marketing and customer demands.
The ISO 13485/2016 Quality Management standard is applicable to companies that manufacture and provide Sanitary Products services, in addition to the people who distribute these.
This course is aimed at students and experts who are interested in knowing the requirements established by ISO 13485/2016 as a Quality Management System for Health products.
The objective of the course is to gain the competences, skills and attitudes necessary for the knowledge of a Quality Management System for Medical Devices based on the ISO 13485/2016 Standard.
At the end of your training action you will be able to:
•Understand what a Quality Management System is.
•Analyse the object and scope of the ISO 13485 Standard. Medical Devices.
•Identify the requirements that the ISO 13485 Standard establishes for the implementation of a quality management system for Medical Devices.