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 ...
Embedded device manufacturers will need to be able to regularly deliver software updates over-the-air Credit: adobe.stock.com Compliance with the European Union’s Cyber Resilience Act (CRA) is ...
Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...
In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
Autonomy isn't free; rather, it's financed by sophisticated oversight systems that enable safe and reliable autonomous ...
The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, ...
We missed this earlier: On October 21, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare (MoHFW), released draft guidelines for granting licences ...
A letter signed by no fewer than 17 different groups is urging the Federal Trade Commission (FTC) to consider introducing clearer guidance for software tethering. Described as “making functions of a ...
Device Drivers are the software through which the kernel of a computer communicates with different hardware without having to go into the details of how the hardware works. It is software that ...
The managed service provides managed laptop computers to staff in a secure, systematically managed, and supported environment. This service is available to all staff that have been migrated to the ITS ...
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