Cloud Computing Requirements for Design History Files for Software Medical Devices

robert.beck

Involved In Discussions
#1
what are the best contents of a DHF for a software-only medical device?

what are the special issues related to cloud computing, as they apply to a DHF?
 
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yodon

Staff member
Super Moderator
#2
Re: Cloud Computing Requirements for Design History Files for Software Medical Device

DHF contents are the same for a software only device as for a mechanical device: you have to show your planning, design inputs (including risk management), design outputs, reviews, verification, validation, etc.

Not sure I understand the second question. Are you asking the implications of storing the DHF (records, etc.) in the cloud or are you saying the device utilizes data stored in the cloud? Either way, there's a high probability that you will need to address 21 CFR Part 11 (Electronic Records / Electronic Signatures).

Either one is probably a huge topic so the more specific the question, the better chance of getting helpful feedback.
 

robert.beck

Involved In Discussions
#3
Re: Cloud Computing Requirements for Design History Files for Software Medical Device

1. I don't see how DHF contents can be the same, except in name only. If you know how software development is done, it doesn't fit the FDA design control structure. I wondered if anyone has had a software-only medical device DHF reviewed by FDA, or at least has built one that they think will pass FDA scrutiny.

2. I agree that Part 11 kicks in when cloud computing is involved, but here I am asking about any special documentation requirements or a list of documents that might be relevant to cloud computing. by cloud computing, I mean that part of the application runs on servers that are accessed via some kind of remote and possibly indirect mechanism. so for example, the medical device is something that you wear or carry and it sends and receives data over WiFi, wireless, Internet, cellular, bluetooth, and so on. at the other end is a server-based application that responds, mostly by collecting data. i can think one type of application where patient data was collected via telemetry in a clinic office, sent by FTP over a modem to a central site, analyzed, and then accessed via web reports. nothing state of the art here, this uses technologies from the late 90's.
 

yodon

Staff member
Super Moderator
#4
Re: Cloud Computing Requirements for Design History Files for Software Medical Device

For 1), a software product (and yes, I have worked on them) *does* have the same DHF contents. As I mentioned, Design Inputs (requirements), Design Outputs (architecture diagrams, state diagrams, interface specifications, database schema, etc.), verification test protocols / results, etc.

I don't mean to sound snarky but do you not create requirements (what the software has to do)? Do you not then translate those requirements into a design (and have some way of knowing that the requirements are all incorporated into the design)? Do you not test the application (and have some way of knowing that all requirements are adequately verified)?

For 2), no, I don't know of any special docs if you're doing things in the cloud. You still have to show that the data is safe (secured, backed up). If access to the data is life-sustaining (and it doesn't sound like it is... and frankly that's a scary thought!) then you may have to take more extraordinary measures to ensure 24x7 access (redundancy, etc.). Generally, some kind of Quality Agreement (which is outside the scope of the DHR but still within the framework of cGMP) with the cloud provider will help facilitate all that.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Cloud Computing Requirements for Design History Files for Software Medical Device

Hi,

IEC 62304 is recognized by the FDA for the process of software validation (and others), so following it will probably give a good starting point when facing any FDA inspection / review of a software medical device:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?id=22436

The recognition page points to some other guidance that may also provide answers to your questions.

Note: I'm not from the software field.

Cheers,
Ronen.
 
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