Free Online Medical Device Development Seminar - Sharpen your skills 2024 - Part 2
Tuesday Oct 22nd, 2024 | 13:30 - 16:30 CET | Free Online Medical Device Development Seminar
Compliant and Efficient Medical Device Development
An impossible combination?
We provide concrete and practical advice on how to meet common and urgent medical device development challenges.
Meet our group of experienced industry experts to share their latest best practices on how to eliminate problems.
Register now to reserve your seat!
Register on Linked In: Click here
We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to
Key Learning Objectives
Decoding IVDR: Simplifying Software Classification for In Vitro Diagnostics
This talk provides key insights into the classification of medical device software under the IVDR, with a focus on standalone software, software with multiple functionalities, and interactions with devices classified under different risk categories.
Through real-world examples, participants will gain practical skills for applying IVDR rules to various software scenarios, including strategies for managing software updates and post-market compliance.
The session will address challenges posed by AI/ML-based software, exploring overlaps with the AI Act and how to maintain compliance in a rapidly changing environment.
Presented by: Dr. Anca-Sarmiza Gültekin-Tigan, Senior Consultant, Quaregia GmbH
Verification & Validation Plan – The most boring or the most important document?
Standards and regulations say that verification and validation of a medical device is a) required and b) needs to be planned. So far, nothing new.
But is V&V planning just a regulatory exercise, or could it contribute to the project effectively?
The talk will show that the V&V plan is the single most important document for the project manager. It defines critical aspects about time and budgets and helps steering the project’s progress. It becomes the project managers “GPS”, showing where he stands. And how long the rest of the way is.
Presented by: Thomas Bohnen, CEO, Keymkr GmbH
Product Requirements – How to keep them manageable and maintainable
In the world of medical device development, crafting clear and effective Design Requirements is an essential, yet often overlooked skill.
Learn through Dr. Lochers analysis of the unseaming consequences of poor writing style and tap into his easy-to-use rules that immediately will improve your requirement writing skills.
In this presentation, Dr. Ivo Locher will share practical insights from years of industry experience, highlighting key best practices that distinguish good requirements from bad.
Presented by: Dr. Ivo Locher, Program Manager, Konplan AG
Design Risks vs FMEA vs Cyber Security Risks – Examine similarities and differences
Risk Management is central to medical device development and manufacturing. From a past, strong reliance on FMEA only, today's risk assessment methods are richer and more rewarding.
In this talk, we’ll compare and contrast different risk assessment types to unveil their differences and commonalities in order to get the most out of each and every type. We’ll also present some data on how real-world medical device manufacturers have chosen to apply different risk assessment methods.
Presented by: Karl Larsson, Managing Director, Aligned AG
Time and Place
- Date: Tuesday, Oct 22nd
- Time: 13:30 - 16:30 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.
Registration
Register to get your online access. We are looking forward to seeing you in this virtual seminar!
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.
