mobile devices (smart phones and tablets)

  1. M

    Challenges Incorporating Mobile Devices into Medical Devices

    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...
  2. Q

    ISO 9001, section 4.3 Determining the scope of our QMS

    Hello Readers 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...
  3. K

    Medical Device Software Version Upgrade Regulation Impact

    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
  4. K

    Ownership of Platform of Software

    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
  5. K

    Accessory - Definition of Accessory According to PMDA

    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...
  6. K

    Will this application require 510k or not ?

    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...
  7. D

    Regulation Approach on Mobile Application which is Medical Device Acccesory

    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...
  8. K

    Importance of Medical Device Accessory Design Controls

    Hello , 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.
  9. K

    Can I consider My medical Application as MDDS ?

    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; The electronic...
  10. K

    Device regulation document for medical application

    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...
  11. K

    Medical Application Classification in Controlled/Uncontrolled by Mobile App State.

    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...
  12. S

    Mobile Phone based Diabetes Monitoring Technology

    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...
  13. Marc

    iPhone and Mobile Device Google Translator

    To view the site on a mobile device, Google has a Mobile Device Translator. Hint: Turn Images OFF.
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