Free Online Medical Device Development Seminar - Sharpen your skills 2023 - Part 2
Tuesday September 26th, 2023 | 14:00 - 16:15 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/freeonlinemedicaldevicedevelopm7105283703521558528/
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
Four things the e-STAR template teaches us about digitalization
On the surface, the FDA eSTAR interactive PDF form was introduced by FDA to speed up the submission process for medical device manufacturers.
But does it? What else comes with it? Is it a threat or an opportunity?
After having created dozens of submissions in the PDF era, we see distinct differences in using the eSTAR template. And these go far beyond the introduction of a new submission format. We have made important insights that we want to share with you.
Presented by: Thomas Bohnen, CEO, KEYMKR
Unveiling FDA's new Computer Software Assurance: What Lies Beneath the Surface!
In the previous year, the FDA unveiled a novel methodology for validating computerized systems in medical device production and quality systems, known as Computer Software Assurance (CSA).
Explore how this stands apart from the conventional Computer System Validation (CSV) method.
How might you adapt your current processes in light of these changes? Additionally, what benefits can you expect from transitioning to CSA?
Presented by: Peter Roka, MedTech Consultant, QUAREGIA
How to avoid Death by Documentation?
Creating and organizing documents may not seem like rocket science, but compiling Technical Files according to MDR, ISO 13485 and FDA QSR 820 is remarkably cumbersome.
This seminar highlights how great savings can be made, using sound structures and digital tools.
We uncover bad documentation practices, their consequences, and potential remedies with the intent to make the medical device documentation process more efficient.
Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG
Time and Place
- Date: Tuesday, September 26th
- Time: 14:00 - 16:15 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.
