LIVE WEBINAR SERIES
Medical Device Software: The Journey from Idea to Patient for Successful Market Access
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. Â
Led by industry experts, these webinars offer in-depth knowledge, practical examples, and strategic advice, empowering you to navigate the regulatory landscape with confidence.Â
- SEPTEMBER 26
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.
- OCTOBER 3
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. Â
- OCTOBER 8
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.
- OCTOBER 17
Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
Types of clinical evidence required, including investigations, literature, technical performance, and similar devices.
- OCTOBER 24
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.