artifical intelligence

Next-level security for AI-based software as medical device

To prove the safety and performance of AI-based software as a medical device, there are special documentation requirements due to data management and model development.

NB’s New Requirements for AI-based Software

Notified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.

Head with Gear Wheels symbolizing AI (Artificial Intelligence) Head with Gear Wheels symbolizing AI (Artificial Intelligence)
Artificial Intelligence, Workshop - Online Event on June 22, 2021

Regulatory Affairs for AI Applications in Medical Devices

The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.

Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine . Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
2019/05/02 - Artificial Intelligence - Updated: 2021/04/16 - Thorsten Prinz

Market Access for Artificial Intelligence in Medicine

How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.