Free Online Medical Device Development Seminar - Sharpen your Skills 2 - 2021
November 23rd, 2021 | 15:00 - 17:15 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/6861944311781588992/
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
SaMD Development is easy, right?
Developing a software-only medical device is by many perceived as complicated and sometimes even overwhelming! The rigid regulations and numerous standards governing medical device development seems to stand in stark conflict with the rapid-evolving design practices and emerging technologies that lie at the heart of software development.
In this webinar, we will compare and contrast the development of SaMD devices with more traditional medical devices. You will learn how to handle challenges unique to SaMD development, in the large and small.
Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, expert at Medical Device HQ
No Risk, No Fun - More Risk, More Gain!
To develop and maintain a risk management file always means a lot of effort. How can we ensure that we get the maximum gain for this effort?
Join us for a deep dive into medical device risk management, its principles and the underlying intentions, and present an approach how to implement state-of-the-art risk management for medical devices. Make no mistake: risk management remains a large effort if you follow this approach. However, with a deeper understanding you will be able to leverage more from this effort, and will experience that risk management sessions may be fun!
Presented by: Dr. Dirk Hüber, Head of Quality, Congenius
Two for the price of One - Using Task Flow Analysis to create your IEC 62366 Use Scenarios
Use Scenarios are the starting point of any IEC 62366 driven usability effort when applying Human Factors and Usability Engineering to medical devices.
But what method shall I use to identify and structure the Use Scenarios for my medical device?
Discover Task Flow Analysis, an efficient and collaborative technique used in several industries to not only identify and describe critical tasks, but also as a useful tool to uncover usability related hazards. This method elegantly describes the context in which the device is used and has a number of benefits that will accelerate your medical device development documentation.
Learn from this session about the processes, techniques, and tool support available for successful IEC 62366 Use Scenario design.
Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG
Time and Place
- Date: Tuesday, November 23rd
- Time: 15:00 - 17:15 CET
- Live Streamed from the Aligned HQ. Sign up to get your access link!
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.
