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 ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

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 ...

Formal methods provide a rigorous mathematical foundation for the specification, development and verification of medical device software. This approach enhances both reliability and safety, which are ...

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 ...

In 2023, the MedTech custom medical software development market will continue growing with projected revenue of $579.40 billion, keeping developers busy. New solutions provide companies with the tools ...

The main market opportunities lie in mastering regulatory decisions for software innovations in healthcare, particularly for digital therapeutics and AI. Navigating complex global regulations ...

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.

ISG has launched a study examining service providers that help medical device companies adopt new technologies and enhance their products.

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 ...