AAMI TIR45 guidance wanted

#1
Hello everyone, i just started working as a quality engineer in a startup company that develops a medical device software using agile method.
however as a beginner there is a lot of terminologies and i'm a little bit confused, i saw a guidance document that i assume it could help me a lot to get familiar with all the wording, does anyone of you have the "AAMI TIR45" for agile software developpement or have a webinar that could help me? it would be very appreciated.
 
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#5
If anyone has experience with this particular TIR, I'm curious to read your opinions. Independent of the TIR content, my suspicion is that the development team has its own ideas of what Agile development means.

The original Agile manifesto included, I believe this statement:

We are uncovering better ways of developing software by doing it and helping others do it. Through this work we have come to value:
  • Individuals and interactions over processes and tools
  • Working software over comprehensive documentation
  • Customer collaboration over contract negotiation
  • Responding to change over following a plan
That is, while there is value in the items on the right, we value the items on the left more.
For medical device software developed per 62304, it will be necessary to have plans and documentation. I don't know what this TIR says, but from my (limited?) imagination, within medical device software development agile methodologies will probably really only work best at the most granular levels of development (of both code and test cases). There are (I believe) some underlying theories of agile development that can be applied to an explicitly non-agile process (e.g. "please don't keep changing the requirements"). I've had someone tell me that they used an agile methodology to develop software requirements, but when pressed on this point it sounded as if this was not much more than 'we talked a lot with the clients before we agreed on the requirements (which went into the contract)'.
 
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