Is it even possible?

Join our event! Concrete and practical advice on how to meet common and urgent medical device development challenges.

Benefit from meeting our group of experienced industry experts who share their latest best practices.

This session will share key software and cybersecurity lessons learned from a recent FDA 510(k) submission, with a focus on the agency’s evolving expectations for documentation and detail.

I will highlight how FDA “guidance” often translates into mandatory, compliance-critical requirements that must be addressed to achieve clearance.

Attendees will gain practical insights to better align R&D and RAQA efforts with current regulatory expectations, avoiding surprises and delays.

Speaker: Paul Gardner, Head of Development, Ypsomed Selfcare Solutions

Inconsistencies in design control are one of the main reasons for critical audit findings. My experience of a somewhat challenging FDA audit has taught me that, with the correct data structure in place, straightforward logical checks can effectively identify most of these weaknesses in advance.

My approach automates these checks for the entire dataset. Using risk management as an example, this presentation shows how such models can be used to increase development efficiency while ensuring audit security.

Speaker: Udo Warschewske, COO, Senior Consultant, MBA, Tecurat

What are the key factors to address in an AI/ML device submission?
• Transparency with respect to AI/ML performance and data used to train / validate the model.
• Using best available methods for reference dataset
• Ensuring generalizability to the intended patient population
• Post-market considerations with respect to monitoring AI/ML performance and regulatory oversight

Speaker: Richie Christian, Senior Medical Device Consultant, Wega Informatic AG

In medical device documentation, you are faced with the promise and dilemma of Design Control reuse sooner or later. Re-using existing data seems like an obvious choice. On the surface, it saves work and speeds up development.
But today's most favoured re-use option (Copy Paste) is a blessing in disguise.

How can real Design Control re-use be achieved with modern digital tools? In this session, we'll explore the use of centralized, curated Design Control libraries as a single-source of truth for properly reused content across multiple projects with full traceability.

Speaker. Anders Emmerich, CEO Aligned AG

Time and Place

• Date: Tuesday, October 21st
• Time: 14:00 - 16:00 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.