All Courses

web-seminar

In vitro Diagnostic Medical Device Regulation (IVDR) – Time for Change – The Basics of IVDR

In vitro Diagnostic Medical Device Regulation (IVDR)
New web-Seminar!
web-seminar

Cosmetic products in the EU - What you should know about the Cosmetics Regulation (EC) No 1223/2009 and beyond!

The web-Seminar will take place in two sessions (2 hours per session).
e-learning

Session 1: Implementation Strategies for IVDR – Timelines and Priorities – Work Packages

This first IVDR e-Learning session is focussed on how to kick-off the implementation planning for the IVDR transition. Based on an exemplary transition plan, priorites as well as work packages...
e-learning

Session 2: When Medical Devices and IVDs meet REACH

This IVDR e-Learning session is focussed on how the REACH regulation on chemicals impacts your IVDs. The session will provide you an idea on how to monitor critical product components and what to do when your IVD contains substances of concern or...
e-learning

Session 3: Classification under IVDR – Challenges and Opportunities

This IVDR e-Learning session is focussed on potential re-classifications of your IVDs and the respective impact on your conformity assessment procedures. Based on practical examples, we walk you through the actions and steps to be taken...
e-learning

Session 4: Roles and Responsibilities of Economic Operators under the IVDR

This e-Learning session is focused on the impact of the IVDR on economic operators such as manufacturers, importers and distributors. It helps you understand how obligations were shifted and provides answers to the most commonly asked questions...
e-learning

Session 5: Performance evaluation and clinical evidence under the IVDR

This e-Learning session is focused on how to analyse data to establish and/or verify of the scientific validity, the analytical performance and the clinical performance of your IVD device in order to prepare...
e-learning

Session 6: Update of the Technical Documentation Under the IVDR

Within this e-Learning you will learn how to efficiently update your Technical Documentation, how to handle the need for adapted and/or new reports and how to incorporate the new requirements into your existing structures.
e-learning

Session 7: Post-market surveillance and vigilance under IVDR

Within this e-Learning you will learn what the new requirements for post-market surveillance (PMS) and vigilance are under the IVDR and what the new requirements on trend reporting and post-market performance follow-up (PMPF) include. In the bonus...
e-learning

Session 8: EUDAMED and UDI under IVDR

Within this e-Learning you will get an overview on the main objectives, the underlying regulations, important stakeholders and the overall structure of EUDAMED (European Database on Medical Devices) and the UDI (Unique Device Identification) system...
e-learning

Session 9: IVDR – Hands-on session with a virtual IVD example from IVDD to IVDR

Within this e-Learning we will take you by the hands to show you based on a virtual example what points need to be considered when starting the IVDR transition adventure – from the initial thoughts up...
Postponed to autumn 2021!
on-site

Design Process versus Design Control "Europe meets USA"

Design Process vs. Design Control "Europe meets USA"
New!
New!
New!
New!