Free Online Medical Device Development Seminar - Sharpen your skills 2023 - Part 1
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Tuesday May 9th, 2023 | 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 with you.
Register now to reserve your seat!
Register on Linked In: https://www.linkedin.com/events/7054018013661949952
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
Why Medical Device Companies are Rubbish at Requirements
After having had thousands of people write requirements during my design control courses, I am not impressed. Requirements engineering appears to be seen only as a regulatory requirement, not something that is value-adding.
This will be a crash course on requirements engineering for medical devices, including how to write user needs and design input requirements.
Presented by: Peter Sebelius, CEO and Consultant, Medical Device HQ
If everyone comes first - they all come last! Escaping the Risk PMS / Clinical Deadlock
MDR has huge demands on our documentation system as well as on the integrity of this system. Errors can have significant consequences in the filing of our devices.
This is particularly true when working with automated procedures for approval workflows or with distributed engineering teams, which care about their individual documentation tasks and the interactions needed to fulfil them. As a consequence, the documentation release takes too much effort to get the line tight and clean.
Based on implementation of timing diagrams, we want to show options to set up the sync-points, synchronization issues to get effective roll-outs.
Presented by: Stefan Bolleininger, CEO, be-on-quality GmbH
Post-Market Surveillance under MDR (IVDR) – not a regulatory burden only
Despite the burdensome regulatory requirements in terms of post-market surveillance of medical devices (and in-vitro diagnostic devices), the manufacturer actually has a great opportunity to create value-adding data during the PMS. With a well-planned strategy, where the manufacturer makes conscious choices when applying the available state-of-the-art methods, questions of concern, data sources and methods, an increased knowledge about the devices within the post-market phase will ensue.
This session will provide an idea of a value-creating, dynamic PMS, showing how this activity is not a regulatory burden only.
Presented by: Werner Knopp, Managing Director, Keymkr GmbH
Documenting Cyber Security in Design Controls and Traceability
The large amounts of Cyber Security standards and guidances released for medical device development during the last few years reflects the increased importance of this domain. But how do medical device manufacturers implement these guidances, and how are they documented in real life?
In this talk, we will look at a number of examples and approaches that reflect how companies chose to implement Cyber Security for Medical Devices.
Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG
Time and Place
- Date: Tuesday, May 9th
- 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.
This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.
