Medical Device Software has gained momentum in recent years, specifically the attention from regulators to address the complexities and challenges software bring in this highly regulated industry.
Software development in the Medical Device/IVD industry is challenging, particularly since integrating cybersecurity and artificial intelligence/machine learning. Regulators struggle to keep pace with the advances in software technology and in finding a balance between innovation and compliance, ultimately allowing release of products that are safe to use.
This webinar will unpack some of these challenges to help understand the current regulatory climate, specifically in the area of cybersecurity and AI/ML. We will include an update on how regulators are addressing these topics and provide a practical perspective on how manufacturers can best respond to the challenges.
Yervant has spent the last 20+ years in the Medical Device field, including both manufacturing and product development. His expertise lies in Regulatory Strategic Planning, particularly in the United States, Europe, Canada, Australia, and New Zealand markets, and in Product Development and Design Controls, specifically in software and with active devices. Coupled with his experience in Manufacturing Processes, Quality Management Systems (ISO 13485 and MDSAP), and Product Lifecycle Management, he brings a comprehensive skill set to support clients navigate through the variety of regulatory pathways and requirements.