An intensive one-day training course on how to establish and improve compliance with the requirements of this standard for medical device manufacturers.


ISO 13485:2016 is the international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. This version of the standard includes significant changes in requirements contained in the previous 2003 version.

Learning Objectives

This course is designed to show how the standard is constructed, and how to interpret the requirements contained in the standard. In addition the impact of revised and new requirements contained in ISO 13485:2016 compared to ISO 13485:2003 are also examined in detail.

Course Format

The course presents the standard comprehensively by interactive sessions as well as formal presentations, specifically

The requirements contained in the standard.

Key differences between ISO 134845:2003 and ISO 13485:2016.

This involves syndicate activity to compare existing and proposed requirements

How compliance with the standards requirements is assessed by quality system registrars.

This can also include CMDR/CMDCAS assessment with the Canadian Medical Device Regulation SOR 98-282 if requested.

Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course.

Delegates also receive a "Certificate of Attendance"

Contact us for detailed training agenda and prices