Understanding EN ISO Course Outline Whether you’re new to the Quality System requirements of EN ISO 13485:2016 or familiar with superseded versions of this standard this course will fill in the gaps for you. Guiding you clause by clause through the requirements of EN ISO 13485:2016, you will gain a good understanding of this key industry standard. For those new to the requirements of a Quality System you will gain the knowledge and understanding to develop and implement a quality management system with your organisation. Those that currently operate to an older version of this standard will gain the relevant knowledge and confidence to update their quality system in line with the significant changes introduced by the 2016 update.
13485:2016 Medical Devices