Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform for managing regulatory submissions, tracking registrations, and ...

In medical device development, things don’t go quite as you planned the first time around. This article shares what to really ...

As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

All startups must navigate the “Valley of Death” as they transition from initial discovery and ideation to market launch. This critical period, characterized by heightened risk of failure, is ...

ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The ...

Despite the fact that medical device software can evolve far faster than traditional medical hardware, manufacturers must go through the same resubmission process for a new software version as they ...

Surgical navigation and robotic systems are not novel technologies and have had a historical presence since the 19th century. Surgical navigation is a result of evolution from a frame-based stereotaxy ...

Gastrointestinal (GI) endoscopes, which are flexible instruments used for visualizing and performing procedures in the GI tract, play a crucial role in diagnosing conditions and conducting less ...