I'd like to start a thread to discuss challenges associated with incorporating mobile devices into medical devices.
There are several applications:
Mobile device is intended to replace an existing wireless controller. This was discussed briefly in another thread.
Mobile device used to...
One of the core business of our company is repairing mobile phones we receive from our customers.The company is going for ISO 9001:2015 certification
Will it be alright to define the scope of QMS as
'Service & repair of mobile phones'
The clauses that is not applicable...
We are making an mobile application which is an accessory to the already existed medical device .
So in case of FDA , Can anyone please tell us what will be regulatory impact in case of
1) application version upgrade
2) mobile platform OS Upgrade
We are making an application which is an accessory to the already existed medical device .
Our question is ,
? Can anyone tell us about the ownership of responsibility of Tablet PC or underlying platform (hardware and platform software) if Application is deployed on consumer Tablet PCs
We have made a mobile application in which we have difficulty to regulate it .
We dont know the application We could not determine if our application is an accessory to the base medical device , since we could not find the definition of ?accessory? on PMDA site.
So can anyone tell us the...
I have mobile medical application which is the accessory of the device which is classified under class 2 . Now my medical application is controlling that device , then should I classify my application as per this text ..
Accessories to classified devices take on the same classification as the...
I want to regulate a mobile application which is an accesory to already existed medical device so what should i include in my regulation study.?
What are the regulatory bodies should i include?? What are the new Guidance documents ?? As i have seen medical device documents on europa website. And...
My questions is about design control .
1)Is it a part of general controls/ Special controls ?
2)If I am making the mobile application as an accessory to the existed medical device then how important this design control is ?
Thanks in advance.
MDDS Defination is ..
A medical device data system (MDDS) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:
The electronic transfer of medical device data;
I know the question is very subjective but please share your opinion .
I was asked to write regulations for a medical application which is an accessory to already existed medical device . I gave him write up from a link of FDA regulations But they are not convinced . I gave him write up from...
We are developing a mobile app as an extension to an existing medical device. This application will use image / video from the medical device .
My Questions :-
1 ) what will be the class of the accessory ? in case of
a) Mobile application is controlling that existing medical...
With an ever-growing population of Diabetes world-wide, there is an increasing market for self blood-glucose monitoring devices. Current glucose monitors are vital for patients but also a hassle for those on-the-go.
In the age of connectivity and escalating & inevitable mobile usage, an...