Regulators from the US, Canada, and the United Kingdom unveiled 10 principles to guide the development of good machine learning practice for medical devices. The principles are meant to be used to ...

IMDRF finalizes good machine learning practice, software risk documents The International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents ...

The Transparency Principles emphasize the effective communication of relevant information about a MLMD to users, such as the intended use(s), device development, device performance, and method for ...

As generative artificial intelligence is incorporated into medical device technologies, there are undoubtedly going to be questions. What are the safety measures that should be enacted? Are there any ...

A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also ...

The integration of artificial intelligence (AI) and machine learning (ML) in oncology clinical trials is rapidly evolving alongside the broader field. For example, AI-driven adaptive trial designs may ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...