Agile SOP for SaMD

nbonds007

Starting to get Involved
#1
Hello!

I am working for a startup SaMD company and they have decided to use Agile for software development. Between IEC 62304 and AAMI TIR45, I'm having a difficult time trying to write a procedure. Does anyone have a template that they can share? I just need a decent starting point and then I can tailor it to our companies needs. Thanks.
 
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yodon

Staff member
Super Moderator
#2
What specific difficulties are you having? Do your SaMD products require premarket clearance (510(k) or CE marking?

I know with Agile, the emphasis is on functionality rather than documentation; but I believe for medical device products, it's best to build up your documentation through the iterative cycles. You have substantial postmarket activities required once you release so factor that in to your planning.
 

nbonds007

Starting to get Involved
#3
What specific difficulties are you having? Do your SaMD products require premarket clearance (510(k) or CE marking?

I know with Agile, the emphasis is on functionality rather than documentation; but I believe for medical device products, it's best to build up your documentation through the iterative cycles. You have substantial postmarket activities required once you release so factor that in to your planning.
The difficulties that I'm having is a smooth process flow. Right now, it's a 34 page SOP. The first part of the SOP talks about software development in general. The meat of the SOP breaks it down by Agile Project Phases.
1) Project Initiation
2) Preliminary Analysis
3) Increment
4) Increment Completion
5) Release Layer Completion
6) Released
7) Retirement

Each of the Phases breaks it down to details of what is performed. Maybe I'm just not used to a procedure that is longer than a Quality Manual :| Or maybe I just need to talk it out with other professionals in the field.

The SaMD will require both premarket 510(k) and a Technical File.
 

yodon

Staff member
Super Moderator
#4
My preference is let the SOP say "what" and push "how" out to a work instruction or the likes. And bear in mind that flowcharts or other graphics can communicate sometimes better than just text. You might consider using the structure of 62304 (at least parts - some of the organization is less-than-desirable IMO) and then mapping your process onto it.
 
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