LIVE WEBINAR SERIES

Medical Device Software: The Journey from Idea to Patient for Successful Market Access

Are you developing software that impacts patient health?

This five-part webinar series is designed to guide manufacturers through the complexities of bringing Medical Device Software (MDSW) to market. Each session will cover crucial aspects from initial concept to regulatory compliance, ensuring your software meets all necessary standards for successful commercialization.  

Led by industry experts, these webinars offer in-depth knowledge, practical examples, and strategic advice, empowering you to navigate the regulatory landscape with confidence. 

Medical Device Software Webinar Series

What we'll cover

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

In this introductory session, we will explore the common challenges manufacturers face when entering the Medical Device market.

From Concept to Market: Comprehensive Market Access Strategies for MDSW

In-depth insights into key aspects of market access, commercialization strategies, and other critical factors for a successful MDSW launch.  

From Requirements to Code: A unified MDSW development cycle that covers all requirements

Requirements for different safety classifications and insights into the development expectations from Notified Bodies (NBs) and the FDA.

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Types of clinical evidence required, including investigations, literature, technical performance, and similar devices.

From Paper to Practice: Technical Documentation Essentials for Medical Device Software

This last webinar will guide you through creating the essential technical documentation for your Medical Device Software.

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.