HSA
The article provides a general overview of the regulatory requirements for software medical devices intended to be marketed and used in Singapore.
HSA
The new article provides additional details regarding the quality management system, explaining how it should be implemented in software medical devices.
HSA
The new article describes the key steps and requirements associated with pre-market product registration in the context of software medical devices intended to be marketed and used in the country.
HSA
The new article provides an overview of the activity controls introduced to ensure operations conducted by medical device manufacturers (software developers) align with the relevant regulatory requirements.
HSA
The new article provides recommendations and clarifications on a broad range of matters with a primary focus on the ones related to cybersecurity considerations for software medical devices intended to be marketed and used in Singapore.
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