Understanding ISO 13485 : 2016

The safety of medical equipment is a fundamental priority for Canadians, as it ensures the protection of patients and users while reinforcing confidence in the healthcare system. That’s why ISO 13485 plays such an important role. This international standard sets out strict requirements for quality management systems for medical devices, to ensure their safe design, manufacture and use. It provides an essential framework for companies wishing to meet the high expectations of quality and regulatory compliance, while contributing to the continuous improvement of healthcare practices.

Target clientele

This course is aimed primarily at management personnel and, more generally, all staff who want to discover and understand the standard, or staff who, although already somewhat familiar with the standard, nevertheless want to refresh their understanding of the requirements.

Course objective

The aim of this course is for participants to develop a good understanding of each of the clauses of 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.

Content

The course covers the following topics:

• Concepts and definitions
• Management commitment
• Resource management
• Product realization
• Measurement, analysis and improvement

Prerequisites

There are no prerequisites for this course. However, some knowledge of medical devices will help maximize the benefits of the course.

Duration

1 day (7 hours)

Evaluation

None

Rates

• 575 $ / participant in virtual class
• 625 $ / participant in classroom
• Request a quote for a private group session