Digital Health worldwide has had a massive growth in recent years, including new technologies in the healthcare space for both consumers and healthcare practitioners, such as wearable technologies, health apps and connected medical devices. This growth has also led to changes in the regulatory landscape of medical device software, either as a stand-alone device or within a hardware medical device system.
The webinar will aim to cover classification of Medical Device Software, especially the challenges with borderline medical devices. It will include an overview of the regulatory pathways to market for Europe, Australia, and the USA and how these have been strengthened. The webinar will also cover key technical considerations for software development, such as use of software standards, Risk Management, establishing a Technical File and Quality Management System to an approved standard. Finally, software specific areas will be covered and the regulatory considerations around them, such as Artificial Intelligence and Machine Learning (AI/ML), Cybersecurity and post-market continual monitoring.
Key learnings:
- Classification of software, either as a stand-alone device or within a hardware medical device system
- Regulatory Pathways and considerations in key markets
- Тechnical considerations to apply to software development
- Artificial Intelligence, Machine Learning and Cybersecurity considerations
