Date: 19 March 2018
Duration: 1 Day
Location: Amsterdam area, The Netherlands
Costs: Regular € 450.-
Early bird € 400.- (until 22 February 2018)
ISO 13485:2016 is moving to become the basis of regulatory requirements worldwide for the medical device industry. You have until March 2019 to update your current ISO 13485 certificate to the new version.
The EU-harmonised EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012; therefore Qserve offers a training course which introduces you to the new and revised requirements and explores the changes between ISO 13485:2003/EN 13485:2012 and the latest standard.
This course gives you a practical insight how you’ll be able to identify the gaps in your current Quality Management System (QMS). We teach you how the standard is structured and how it needs to be read and implemented.
In this course, we will explain how the standard relates to ISO 9001 and ISO 14971, and how it might be used to integrate requirements of CE (current and future) and FDA as well.
This course will also provide insight for IVD manufacturers, relating to the upcoming changes in the IVD regulation with regards to QMS related requirements.
At the end of this course delegates will be able to define the:
- Explain the use of ISO 13485:2016 as the basis for a QMS for IVD and medical device manufacturers
- Identify the relationship between ISO 13485:2016 and European Medical Device and IVD Directives
- Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide
- Understand the transitioning of your CE certificates in line with ISO recertification.
This 1-day training course will be delivered by a very experienced Qserve tutor.
Who should attend:
Everyone that comes across ISO 13485:2016 in their daily job and would like to get to know more.