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Lead Auditor EN ISO 13485:2021 and EU IVDR 2017/746 - Regulation - Webinar (Recorded)

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Webinar
90 Minutes
April 2023
Region: Europe
Compliance Online
ID: 5758886

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Why Should You Attend:

This webinar will provide an in-depth understanding into the following

Introduction, who must apply the EU IVDR 2017/746 requirements?
Overview about the changes of the EU IVDR 2017/746 regarding quality management
What is the relationsship between the EN ISO 13485:2021 and the EU IVDR 2017/746?
Which new requirements of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2021? The Role of the new harmonized version?
Smart and fast ways to implement the changes in your quality management system
Fast track internal audit to approve the changes

Agenda

The new scope of the EU IVDR 2017/746
The obligations and roles of the EU IVDR 2017/746
How work the regulation and the EN ISO 13485:2021 together?
New and updated processes required by the EU IVDR 2017/746
How to implement the required changes?

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This product gives access to the selected training webinar. Please select an access option from the list below. This product gives access to the selected training webinar. This is a single delegate licence. This allows access for one delegate. The recorded webinar can be accessed through a secure website. Username and password will be sent via email.

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€243EUR$249USD£203GBP

One Delegate Online Access (Recorded)

This product gives access to the selected training webinar. This is a single delegate licence. This allows access for one delegate. The recorded webinar can be accessed through a secure website. Username and password will be sent via email.

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Why Should You Attend:

This webinar will provide an in-depth understanding into the following

Agenda

Related Topics

Related Products

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (March 13, 2025)

The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 (Recorded)

ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

Non-Conformance and Corrective Action for Medical Device Manufacturers Training Course (December 12, 2024)

ISO 50001 - Fundamentals of Energy Management System (EnMS) E-Book