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 ...

Variscite and medtech engineering company NRG have announced a partnership aimed at helping medical device developers.

HiArc to showcase integrated control system HiArc Ctrl at ADLM 2026 ADLM 2026, July 26–30, Anaheim Convention Center, Anaheim ...

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 ...

By Joseph M. Saunders, Founder and CEO, RunSafe Security A medical device cleared today may stay in clinical service for 15 ...

The goal of medical device software development should be to select a process and architecture that ensure a safe and effective product. The methods utilized to achieve this goal differ among medical ...

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 ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

A practical guide to the FDA line between a wellness app and a regulated medical device, how AI features change it, and what to do if your app crosses over H1: Is Your Healthcare App a Medical Device?

In recent years, pharmaceutical companies have broadened their horizons, moving beyond drug development to enter the medical device market. This strategic shift allows pharma to offer integrated ...