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 ...

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, ...

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 ...

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 ...

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 ...

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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 ...

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 ...

For SLAS US 2023, we speak to Guy Starbuck, one of the co-founders at AIQ Global, about how we can utilize AI technology to bring new medical devices to market. Please could you introduce yourself and ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...