Online / Cloud Based Software as Medical Device

#1
Dear all,

Currently I am working on a medical device product which might comprehend an online server. Depending on our strategy this online server might be qualified as a class IIa medical device which has to be approved by a NB.

I now had a look if I could find online servers which have a NB approval. To me it would make sense that there would be class IIa (or higher) online tools available.

Question: does anyone have examples of online (software) tools approved by a notified body?

Thanks!
Ralf
 
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Sam Lazzara

Trusted Information Resource
#2
I don't think a general computer server (online or not) would meet the definition for a medical device, so I think it is doubtful you will find what you are seeking. Take a look at the definitions for medical device in the MDD and MDR and decide for yourself.
 

FoGia

Involved In Discussions
#3
It depends on what you mean by 'online server', for instance if it's a website that provides an interface to plan a treatment it will be considered as a medical device.
 
#4
I will try to explain a bit more: the server in mind will not 'just be a database' or a collection of data. In that case it would indeed not be a medical device I think. The idea is that the server/website/api will determine things like heart rate and/or a cardiac event from say e.g. raw ecg data.
How I read the MDD/MDR and the appropriate MEDDEV's and bordeline document this is then considered medical device software.

Theoretical example: an online tool where which you would upload an ECG record from e.g. a holter monitor and the software returns a time stamp where it suspects a cardiac event.
 

Marcelo

Inactive Registered Visitor
#6
Question: does anyone have examples of online (software) tools approved by a notified body?

Thanks!
Ralf
Nope. There's no approval by a Notified Body in CE Marking (they verify the conformity assessment steps), and even so, if CE Marking for medical devices are for medical devices (including software as medical devices), not for servers.
 
#7
As a reply to both questions:

I am looking for examples of other companies having NB approved software running on an online/cloud server.
As for that I am aware that the hardware of the server is not to be approved. I guess its a difference in dictionary, but I am not considering the hardware of the server but the software.
 

TomaszPuk

Starting to get Involved
#9
While developing an MD for a cloud I would try to disconnect from HW considerations (bare metal deployments). If you look at database services like Relational Database Service RDS on Amazon Web Services you do not specify precisely HW configuration of such a service. Of course you can select a database server version and configure the processing power of RDS but you do not speak about physical hardware any more.

I would still advice to do the following:

  1. SDLC* - Document your technology choices e.g. RDS service as infrastructure and let's say mySQL database as w service in Technology Stack Specification
  2. SDLC* - Perform risk analysis for the chosen technologies and define risk control measures
    1. I would guess that the reliability of services such as RDS is much higher then the reliability of most bare metal deployments
  3. PLC** Solution Providing phase - Implement security measures that will monitor your core infrastructure as a part of Service Operations Plan to indicate any problems upfront
  4. PLC** Solution Providing phase - you can configure RDS in such a way you have control over the patching (change control)

I think that should do the job.

If you have problems with that approach you can think about reserved instanced of your service or you can go for third party services specializing in such qualified / validated infrastructure delivery for health sector.

* SDLC - Software Development Life Cycle (IEC 62304)
** PLC - Product Life Cycle (ISO 13485)
 
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