La gestion de la qualité pour
les appareils médicaux
A framework for medical excellence: ISO 13485
The safety of medical devices is a fundamental priority for Canadians, as it ensures the protection of patients and users while strengthening confidence in the healthcare system. That is why ISO 13485 plays such an important role. This international standard sets strict requirements for medical device quality management systems to ensure safe design, manufacturing, and use. It provides an essential framework for companies seeking to meet high standards of quality and regulatory compliance, while contributing to the continuous improvement of healthcare practices.
Our various training courses offered on the subject
Understanding 13485 : 2016 – 7 hours
Course Objective
This course aims to help participants develop a solid understanding of each of the clauses in ISO 13485:2016, how they are interrelated to create a dynamic quality management system that contributes to the achievement of the organization's quality objectives in line with its strategic objectives.
Target audience
This course is primarily intended for management personnel and, more generally, any staff who want to learn about and understand the standard, or staff who, although already somewhat familiar with the standard, want to refresh their understanding of its requirements.
Content Elements
The course covers the following topics:
- Concepts and definitions
- Management commitment
- Resource management
- Product realization
- Measurement, analysis, and improvement
Notes
There are no prerequisites for participating in this course. However, some knowledge of medical devices will help maximize the benefits of the training.
What if it wasn't exactly training you needed?
Beyond knowledge development, we also offer personalized support: assistance in obtaining your certification, maintenance of your management system with an experienced part-time resource, or strategic support to improve your processes.
Whatever your situation, we are here to help you move forward effectively.