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 ...

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 ...

To protect both the user and patient, medical device developers must pay strict attention to the safety of a device's software. Risk-mitigated software design is crucial. Timothy Cuff and Steven ...

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

Clinical decision support (CDS) software plays an increasingly central role in health-care delivery, yet the ambiguous interpretations of regulations result in inconsistent application in clinical ...

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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 ...

The Transparency Principles emphasize the effective communication of relevant information about a MLMD to users, such as the intended use(s), device development, device performance, and method for ...

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 ...