An impossible combination?
Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2021.
We have called on a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.
Register on Linked In: https://www.linkedin.com/events/freeonlinemedicaldevicedevelopm6773634480822353921
Let me take you on a holistic walk through the act of developing a medical device, joining dots rather than picking on a discrete activity.
There is a lot of common sense that underpins the regulation but it seems lost in both presentation and interpretation.
Taking a step back and asking: “Why are we doing this?” can help you to see the woods beyond the regulatory trees.
Presented by: Mike Heald, CEO, Commala
Medical device software risk management is often perceived as complicated to understand and work with – it is not!
In this seminar, you will not only get the foundational understandings, but you will also understand how to practice medical device software risk management!
Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, trainer at Medical Device HQ
If you want to create medical devices that people love, then usability, user experience (UX), and ergonomics is the road forward.
We will describe how you can establish a human-centered development process and how using prototypes with real users during the early stages can provide new and powerful insights.
We will explore the usability and human factors engineering regulatory underpinnings and their relation to ISO 13485.
We will dissect which types of use-related risks exist and how they can be analysed according to ISO 14971 during your product development.
Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH
If you thought you had covered Eudamed by implementing UDI's, then think again!
In this talk, we will address the deliverables required by medical device manufacturers, how to use medical device codes, how to communicate with the Eudamed servers.
We'll describe how to deal with legacy devices and how you can best organize your work to efficiently meet the Eudamed challenges ahead.
Eudamed is coming for you. We will help you prepare.
Presented by: Richard Houlihan, CEO, Eudamed Ltd, former technical manager for Eudamed 2 and MDR EUDAMED July 2017 - April 2019
Having spent years developing and documenting a medical device just to get it rejected by a Notified Body or the FDA is a costly and disheartening experience.
Are there other ways than lengthy reviews to find and eliminate inconsistencies in your Technical Documentation?
Learn from this session about strategies, techniques, and methods for finding, eliminating, and avoiding errors in your Technical File.
Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG
Presentations are held in English.
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.
Register to get your online access. We are looking forward to seeing you in this virtual seminar!
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.