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 ...

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...

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 ...

In a member webinar hosted by techUK, experts from the Medicines and Healthcare products Regulatory Agency (MHRA) provided a comprehensive introduction to the UK’s regulatory framework for software as ...

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 ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

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Researchers from Tokyo Institute of Technology highlight the diverse and emerging nature of SaMD, its growth potential, and transformative impact on healthcare services, in a new study. There has been ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, has ...

The survey conducted across consumer goods, high tech, industrial equipment, and medical device industries found medical device companies passing up the ability to streamline product operations with ...