There isn’t necessarily one “standard” for medical device software. Instead, multiple standards may be applicable, depending on the device and software involved.

For example, some common standards for medical device software include requirements from the FDA (USA), ISO 13485 (international), and IEC 62304 (software safety). However, many other standards may apply to a particular device or software.

There isn’t necessarily one “standard” for medical device software. Instead, multiple standards may be applicable, depending on the device and software involved.

For example, some common standards for medical device software include requirements from the FDA (USA), ISO 13485 (international), and IEC 62304 (software safety). However, many other standards may apply to a particular device or software.

It’s important to work with a qualified team familiar with the relevant standards for your project. That way, you can ensure that your software meets all the requirements.

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