Re: [scrumdevelopment] FDA and Scrum?
- Hi,Till very recently i was working with a European Manufaturer of Medical Devices. The team which i was working with was using SCRUM and due to organisational requirements needed to be compliant to both CMMI L5 / FDA and ISO13485 .This project has been subject to multiple audits ( CMMI/ FDA as well as ISO13485 ) and have come out every time with flying colours. And what i have seen is that SCRUM complements the implementation of CMMI , ISO13485 standards as well as regulatory requirements. This definitely was not success at the first shot , it took the team almost a year to settle down into a comfortable way of working with all the framework requirementsI don't think that the tools need to be FDA approved instead what FDA looks for is whiter the tool has been formally evaluated by you with the perspective of it end use . FDA will look for tool evaluation reports and the process of doing tool evaluation. And yes there is a lot of focus on the tooling to ensure the smooth functioning of the team.And unless you management is really convinced about the Agile - SCRUM concept , and they attribute enough resources to the project ,it would be difficult to do all these things .Thanks & RegardsAnoop Wilson
On 6/28/08, Jurgen De Smet <jurgen@...> wrote:
There should be enough Americans out here that might have experience
implementing Scrum and complying to FDA regulations. I'll be
confronted with this FDA animal later on during the year and was
wondering what the experiences are in relation to efficiency,
productivity, level of waste to add...
In all cases thanks for your feedback.
Thanks & Regards,
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