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Introduction

In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. The presentation is conceived as a practical demonstration of how to meet post-design requirements of ISO 14971. We will review the production and post-production requirements of ISO 14971 as stated in Clause 9 and interpret their meaning for the medical device industry. The presentation will use practical examples of the application and use of risk management information as well as determine when risk management files need to be updated. We will also review the requirements for Management Review of risk management activities in the post-design portion of the product lifecycle, and present examples of how to meet these requirements.

Venue

Online Training Webinar

Online Training Webinar, United States

Useful links

Organised by

GlobalCompliancePanel

Contact information

Mr Manzoor
United States of America
800-447-9407
Contact us by email

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