EN ISO 13485:2016

The harmonised EN ISO 13485:2016 standard can be used to show compliance with the regulations and constitutional requirements needed for companies supplying medical devices and associated services in the EU/EEA. By implementing a quality management system according to this standard, you fulfil many applicable sections of both Medical Device Regulation (MDR 2017/745) and (IVDR 2017/746).

This course explains the requirements of the standard and describe its interpretation and application. The course provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system. Having a quality management system according to ISO 13485:2016 is, in many cases, a prerequisite to getting a CE-mark.

Topics

• ISO 13485 – History, purpose, scope and future
• Quality management system – The big picture, CE-marking
• Relation with ISO 9001 and MDR/IVDR
• Requirements and interpretation of EN ISO 13485:2016
• Quality management systems
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement

Target group
This course is intended for personnel within QA, development, production and management, as well as for internal auditors, process owners, and regulatory staff at companies within the medical device supply chain.

Educational goals
After the course, participants will have a basic understanding of the ISO standard and how to establish and maintain a quality management system based on it.

Recommended prior knowledge
A basic knowledge of quality systems, such as ISO 9001, 13485, GMP, etc. is recommended.

Course presentations
Course material will be in English, verbal presentation and discussions in Swedish.

Course leader
Ladan Amiri, Senior Quality and Regulatory Consultant