Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Enlil launched Milestone View, designed to help medtech teams replace fragile, siloed timelines with traceable, ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

Today’s medical devices are very sophisticated, with more providers serving applications in software as well as hardware. These devices are becoming more intelligent and can be tailored to be ...

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...

Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the MedTech custom medical software development market will continue growing with ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...