Online Seminar for Medical Device Development - Sharpen your skills 2025 - Part 1
- Written byKarl Larsson
- on06 May 2025
- . Posted in
Sharpen Your Skills 2025
Tuesday May 20th, 2025 | 15:00 - 17:00 CET
How to efficiently develop Medical Devices for compliance
Is it even possible?
Join our event! Concrete and practical advice on how to meet common and urgent medical device development challenges.
Benefit from meeting our group of experienced industry experts who share their latest best practices.
Register today to reserve your seat!
Register on Linked In below. For questions,
Key Learning Objectives
Navigating Uncertainty:
Adapting Your Regulatory Strategy Amid U.S. and FDA Instability
Adapting Your Regulatory Strategy Amid U.S. and FDA Instability
For medical device manufacturers, the current US administration's policies and actions have created considerable uncertainty around market access.
In this session, we will analyse how the current FDA situation affects those who intend to introduce their products on the US market and investigate possible ways to approach and mitigate these uncertainties.
Presented by: Jurjen Zoethout, Senior Partner, Lucendra MedTech Consulting
Managing non-redundant work items within the digital thread:
An example of a Risk Management System at Karl Storz
An example of a Risk Management System at Karl Storz
When “going digital”, an obvious requirement is to replace redundant – and thereby inconsistent - information by work items, representing a “single source of truth”. Such work items can then be re-used, wherever required. While data derived from such work item-based systems provide high efficiency consistency, the maintenance of the data can become an issue.
In this session, we will analyse how such maintenance issues can manifest themselves and available approaches of how to address them using the example of a digital Risk Management system established at KARL STORZ SE & Co. KG
Presented by: Martin Schroeder, Senior Risk Manager, KARL STORZ SE & Co. KG
Practical post-market surveillance under the MDR/IVDR
Post-Market Surveillance (PMS) under the MDR/IVDR involves actively gathering and analyzing data on medical devices after these have been placed on the market. But how is this work best organized?
In this session, we analyse how medical device companies of different types can optimize their PMS approach with tips, tricks and best practices from real-world examples.
Presented by: Camilla Messerli, Head Quality Management & Regulatory Affairs, Effectum Medical AG
Digital Usability Engineering and Risk Assessments:
Practical examples using a Medical Device ALM
Practical examples using a Medical Device ALM
Usability engineering and risk management are closely interconnected in medical device development, as both aim to ensure the safety and effectiveness. By integrating usability engineering into the risk management process, manufacturers can proactively identify and mitigate user-related risks.
But how this done in practice? In this session, we'll look at an example of how a design control tool can be used to facility the work of these two types of activities.
Presented by: Karl Larsson, Managing Director, Aligned AG
Time and Place
- Date: Tuesday, May 20th
- Time: 15:00 - 17:00 CET
- Live Streamed from the Aligned HQ. The Teams link is on the Linked In Event page.
Presentations are held in English.
Target Audience
This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.
About Aligned AG
Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.
Register today to reserve your seat!
Register on Linked In below. For questions,
