Medical Device Software - Switch from Waterfall to Agile methodology

#1
Hello All

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.
Currently 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 Agile and Waterfall model?

Thank you
 

sagai

Quite Involved in Discussions
#2
I would first look into this :
- AAMI TIR45:2012

For the question those you have had:
"1. Is Agile methodology compliance with FDA and CE requirements?"
Oh, yes of course.

"2. If we follow agile methodology then, what standard do we follow/refer?"
IEC/ISO 62304 :)2006)

"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?"
Ehh ... the ones are required for your target market approval and for the standards those you claim compliance.
Agile is not an excuse for notdoing I think.

4.Difference between Agile and Waterfall model?
Mindset of the people and the availability of financial resources :)

Regards
Szabolcs




Regards
Szabolcs
 

yodon

Staff member
Super Moderator
#3
Just to follow up on sagai's excellent post, indeed, the documentation requirements for software are laid out quite nicely in IEC 62304. The FDA recognizes both 62304:2006 and ed 1.1 :2015 as consensus standards. The EU has harmonized on the :2006 version. Documentation requirements, though are quite similar.

The agile approach emphasizes functionality over documentation during development but that shouldn't preclude building up your documentation set through the process. Don't wait until the end to create all the documentation (which would be like a reverse waterfall, I guess :) ).
 
#4
This publication is probably of interest: T. Laukkarinen, K. Kuusinen, and T. Mikkonen, ‘DevOps in Regulated Software Development: Case Medical Devices’, in 2017 IEEE/ACM 39th International Conference on Software Engineering: New Ideas and Emerging Technologies Results Track (ICSE-NIER), 2017, pp. 15–18.
 
#5
This publication is probably of interest: T. Laukkarinen, K. Kuusinen, and T. Mikkonen, ‘DevOps in Regulated Software Development: Case Medical Devices’, in 2017 IEEE/ACM 39th International Conference on Software Engineering: New Ideas and Emerging Technologies Results Track (ICSE-NIER), 2017, pp. 15–18.
Yes, this is a really helpful reference for SCRUM w.r.t 62304 requirements
 

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