Tata Elxsi, a global leader in design and technology services, today announced the launch of AnaTel™, an AI-native software ...

AnaTel helps medical device and SaMD companies accelerate software development, generate regulatory-grade documentation, and reduce development cycle times by up to 60%BENGALURU, India, May ...

Medtronic (NYSE:MDT) today announced the establishment of a European software development hub in Galway, Ireland.

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 ...

Tata Elxsi’s AnaTel reflects the growing shift toward AI-native healthcare software engineering, bringing AI-driven ...

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 ...

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

The medical device executive need not be a software expert but must have some understanding of how to oversee the development process. Strong development steps involve properly aligning business, ...

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.

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 ...