On-demand Webinar

Medical device regulation in an increasingly AI driven world

Michael Ward
Head of Thought Leadership, Life Sciences & Healthcare
Mark McCarty
Regulatory Editor, BioWorld Medtech
Dr. Susana de Azevedo Wäsch
Vice President Quality Management, Regulatory & Medical Affairs
Ypsomed AG
Sam Kay
Principal Regulatory Consultant

Although the first AI algorithm was approved by the FDA back in 1995, the technology has really only rapidly expanded in the last couple of years. One of the most recent catalysts within this space has been ChatGPT. The innovation in this area, especially in the medical device and technology space are moving at incredible speed; often faster than regulation. Legislation for these technologies are highly complex for regulators to interpret and translate into regulation that will ensure safety and efficacy without hampering innovation.

Access this on-demand webinar to get answers to questions such as –

  • How should regulators be thinking about regulation for these technologies to ensure they are fit for purpose?
  • How should companies investing in AI and machine learning approach regulation to ensure successful filing?
  • What challenges are companies facing when monitoring, interpreting, and implementing regulation to keep their devices in market?
  • Given the international nature of this area, how can regulation be transparent and harmonized in such a fast-moving world?