Comments on: ISO 62304: The Harmonized Standard for Medical Device Software Development

By: sagai

sagai — Wed, 24 Nov 2010 11:25:40 +0000

Hi,
you are using my intellectual property, check the property field of the IEC62304_Checklist.xls file.
Regards
Sz.

By: Segalit Tsadok

Segalit Tsadok — Mon, 14 Jun 2010 05:01:03 +0000

Yes – this standard will need to be addressed by medical device product development teams in order to pass FDA inspection and get clearance for devices. It reinforces the need for quality standards and development procedures that address ISO 14791 regarding software risk analysis. Like system hazard analysis which relies on the MDD list of Essential Requirements, formal hazard analysis will need to be conducted for software components, as well.

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Sun, 06 Jun 2010 02:56:31 +0000

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Sat, 05 Jun 2010 23:45:15 +0000

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