Medical device software development
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I am very new to this forum so please bare with me...
Right now, we are in the stage of preparing the documents for SDLC (Software Development Life Cycle) for a software which is itself a medical device and also used in medical device like MRI, CT scan machines.
Currntly we are using Waterfall model for Software development. and we are planning to switch from Waterfall to Agile methodology,
we have following queries regarding usage of Agile methodology for SDLC of of medical device software.
1. Is Agile methodology compliance with FDA and CE requirements?
2. If we follow agile methodology then, what standard do we follow/refer?
3. If we follow agile methodology then, what type of documents we need to prepare in SDLC and what shall be the content of this document?
4.Difference between Aglie and Waterfall model?
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In terms of producing documentation for the approval of your software the development model you use is not really significant. You will still need to demonstrate that the user requirements and performance requirements were defined and that the design has been verified and validated to confirm that the requirements have been fulfilled. You will also have to demonstrate that any risks associated with the software have been assessed and appropriate control measures are in place, and have been validated, to reduce risk to a level which is as low as possible.
firstly, per IEC 62304 does not mandatory Agile/ V model. it at the discretion of the device manufacturer to adopt.
a) that, once adopted (if Agile) then, software development plan can state the model and documentation strategy adopted to fit Agile way.
*documentation strategy: can must essentially follow Document control procedures + look at industry standard practices such as:
a) In Sprint documentation and reviews (SW Development plan, URS, SWRS, HLD, LLD, Unit Test procedure, SW sub system Test Procedures, System test procedures etc)
SW Test Plan needs to document to strategy (acceptance criteria) for each level of test (including Unit tests) performed during in-sprints.
Finally, SW development plan can highlight the acceptance criteria for in-sprint.
* in-sprint - first 2 sprints can be development and unit tests, next following sprints upto 6th sprint can Verification scripts followed by approving SW release letter.
let me know if this clarifies your query.