Free Online Medical Device Development Seminar - Sharpen your skills 2022 - Part 2
Thursday October 27th, 2022 | 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/6980537339953479681
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
How to obtain your MDR certificate - Secrets from the Inside
Getting an MDR certificate has become the focus of the majority of medical device manufacturers. As everyone are scrambling for an opportunity to submit their documentation, it becomes paramount to make sure that the technical documentation is complete and consistent. But is this sufficient?
A former Notified Body Auditor gives you insights on how an application is processed and assessed and what you can learn from it. Find out about common pitfalls, best practices, and the fastest way to get to your CE mark.
Presented by: Pontus Gedda, former Technical Manager and Auditor at Intertek, Medical Device Specialist
Formative and summative Usability Evaluations – how to identify use problems and take advantage of them
Formative and summative evaluations are the heart of the Usability Engineering Process for medical devices and software. They are not only essential for the compliance with IEC 62366 but also a tremendous opportunity to fine-tune the design of the device.
Learn how to target Usability Evaluations to generate maximum benefit and accelerate your medical product development process.
Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH
Enter the Dragon - How to get approval for a Medical Device Software in China
With 1.3 billion residents, China is one of the largest medical device markets and a tremendous potential for western medical device manufacturers. But what does it take to accommodate China’s National Medical Products Administration (NMPA) and get the regulatory approvals necessary?
Learn more about how NMPA compares and contrasts to regulations like MDR or FDA from an expert that has already made this journey.
Presented by: Sonja Biernatzki, Regulatory Affairs Manager at Roche Diagnostics
How do you identify ALL risks?
ISO 14971 forces medical device manufacturers to think about all the characteristics that could affect safety. But how do you demonstrate that you have "thought of all charachteristics"? How do you make sure that no risks were missed? How do you argue that you have successfully completed the task of risk identification?
In this talk, we will use examples to explore various methods of risk identification and demonstrate how digital tools can make this process simple and efficient.
Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG
Time and Place
- Date: Thursday, October 27th
- Time: 13:00 - 16:30 CET
- Live Streamed from the Aligned HQ. The Zoom 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.
