From a post for the SoftwareCPR.com website:
In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors.
Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider the intent behind compliance activities and how agile can help better achieve intent.
Let’s start with the intent behind medical device software “compliance.” What’s the point? At the top level, it is building devices that fulfill intended use and do no harm to any user or patient. From a simplified compliance point of view, that means two things:
- Assessing and mitigating any risk of harm before the device is used.
- Establishing ability to determine if and how a device contributed to an actual harm or potential harm situation after the device is used. Corrections can then be made to prevent recurrence.
How can agile help?
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