In Vitro Medical Device Regulation Roadmap (IVDR)
New In Vitro Device Regulation (IVDR)Duration: Unlimited
Cost: 49 USD
This course describes general principles and gives practical advices on how to plan and prepare for the IVDR.
In this course, we will cover all the necessary regulatory references. We will discuss in details an article 56 of IVDR. Moreover, you will learn about general safety and performance requirements. We will also explain what is the performance evaluation and step by step we will guide you through its components. At the end, we will highlight your periodic deliverables so you will be aware on what and when needs to be updated.
In this course, we will cover all the necessary regulatory references. We will discuss in details an article 56 of IVDR. Moreover, you will learn about general safety and performance requirements. We will also explain what is the performance evaluation and step by step we will guide you through its components. At the end, we will highlight your periodic deliverables so you will be aware on what and when needs to be updated.
Length: 00:20
IVDR ISO 20916:2019
New In Vitro Device Regulation (IVDR)Duration: Unlimited
Cost: 49 USD
This course is on Clinical performance Studies under the ISO 20196:2019. This
ISO standard describes in detail the requirements for the planning and
conducting of clinical performance studies.
Length: 00:20
European IVDR Masterclass
New In Vitro Device Regulation (IVDR)Duration: Unlimited
Cost: 79 USD
This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time!
Length: 01:00
Version: 01
Release Date: 12 May 2020