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app (mobile device software)

  1. Ed Panek

    Splitting UI (User Interface) into two development paths

    We have a firmware controlled device that interfaces to the user via a smartphone device. If we wanted to develop a web-based application could we develop unique features on that UI without implementing it on our smartphone app UI? If so, how would the DHF change? Engineering is trying to...
  2. Ed Panek

    Screenshots required for Medical Device Smartphone Apps?

    Hello, We have a medical device that interfaces with the user via a smartphone app. We have extensive trace matrixes and excellent sw documentation. Our CE mark required a document with the screenshots of the app in use. Is this also an ISO 13485 requirement?
  3. R

    Validation of mobile app and cloud servers for data security

    Hello everyone, To ensure the mobile app is securely downloaded from an app store such as Google Play or Apple store, how can a team validate the download is secure from Google Cloud servers? How can these cloud servers be validated? Is it assumed that because it's Google, the download must be...
  4. G

    Alternatives to time apps (mobile applications)?

    It turned out that I do not like to use mobile applications, but sometimes I need to paint my day point by point because I have a very tight schedule at work. Advise a worthy replacement for mobile applications.
  5. S

    Mobile app data privacy - Length of record retention in a software app

    Hi everyone, For how long should customers' data be stored or the length of record retention in a software app, for example, after the license has lapsed. Do customers always have access to their data or is this data destroyed after a certain amount of retention time? Thanks!
  6. S

    In a risk analysis, how can we tie mobile app security breach to ISO 14971?

    Hi everyone, In a risk analysis, how can we tie security breach (e.g. losing confidentiality of patient information) to ISO 14971? What is the severity level of harm for loss of confidentiality of information in a mobile app? I would think we should do that exploitability analysis first as per...
  7. JoCam

    Medical Device Software - Apps which can control medical devices

    Hi All, Is an app downloadable to a mobile phone or tablet that can be connected via bluetooth, wifi or GSM to control an electrical/electronic medical device remotely by a healthcare provider classed as medical device software. The electrical/electronic medical device itself can be operated...
  8. J

    Manufacturing Cycle Time Apps

    Hello All, :bigwave: Was wondering if any one has found a good APP for phone or tablet for monitoring work cycles. I'm looking to be able to measure 1. Start of machine, 2. End of machine Cycle, 3. Part change length to next Start. It seams simple enough, but extremely difficult to find...
  9. N

    Is App that motivates patients to do therapy exercises a medical device?

    Hi folks, I'm pretty new to regulatory affairs but would like to understand whether, for the sake of the MDD 93/42/EEC, a mobile app that uses games to motivate patients to do physical therapy exercises at home would be considered a medical device or not? My understanding is that "motivating"...
  10. A

    End of Life for Medical Mobile App (Stand Alone Software)

    I am looking for guidance on defining end of life for a medical mobile app. How do you define shelf life for standalone software that doesn't have an end of life? Does it have to be predefined? In which case can we assign a random 100 year lifetime to it?
  11. Q

    File Management system in Cloud for Medical Mobile Apps

    I need some guidance for managing mobile medical apps, system config files in cloud, is there any guidance documents for managing DMR (i.e Master media set- Containing System Config file) in cloud for mobile app. Any input/suggestion will be greatly appreciated.
  12. D

    Support Group for Global Quality, Regulatory, and Trade Compliance Professionals

    Fellow Regulatory Affairs professionals, Quality Professionals and Trade Compliance Professionals?I present to you a great resource for getting the answers and support we constantly need in our profession. Our roles in RA / QA / QE and Trade compliance are INFORMATION HEAVY. Without appropriate...
  13. W

    Which ISO certification is ideal for my IT company?

    I wish to know the details of getting which ISO for my IT company? And I need to how it is help to improve my company(IT) strategy?
  14. P

    Need suggestion on Software or App for Tracking Quality Plan Status

    Hi all, I wonder if anyone has come across something that will help me here. Ill need to provide some background, the actual question is at the bottom. My company essentially builds big steel boxes (up to anywhere around 10m x 10m x 5m), although they can be smaller (2m x 2m x 3m or so)...
  15. G

    Nonconformance Categories - QMS web app to support ISO9001

    I'm leasing a QMS web app to support ISO9001. In the NCR module there are 2 levels of NCR classifications, NCR Category and NCR Failure Classification. I was told the NCR Category is a higher level, more general term and the NCR Failure Classification is more specific term. The NCR Failure...
  16. E

    Medical Device supplemented with a Mobile Application

    Hi all, I am a UX designer in a consultant company that develops an app which works together with a medical device. The medical device saves the same data after usage and send this information to the mobile device thanks to the Bluetooth service. The mobile device is being developed by...
  17. L

    Mobile Medical App - Understanding 21 CFR Part 820 Requirements

    Hello Everyone, I am new to the forum and the 510(k) process. I read a lot of your helpful threads but still have a few questions, if you don't mind. For the past four months I've been collecting data for a 510(k) for a mobile med app and so far with lots of reading and samples was able...
  18. N

    Free iPhone app - Screw Thread Calculator

    Was visiting the European Offshore & Energy Exhibition in the UK today and there was a Specialist Manufacturer of Bolts that were promoting an iPhone tool they've released that calculates thread dimensions for Inch Thread Forms and ISO metric threads. Looks a useful little app that essentially...
  19. J

    Mobile Medical Device App Validation Guidance vs. GPSV?

    Hello, I am new to this forum and I am looking for a thread specifically on mobile app validation but I don?t see one. My questions are related to low-risk Mobile Apps and NOT Mobile Medical Apps as defined by the FDA. The FDA has indicated they intend to exercise enforcement discretion for...
  20. P

    Is a new 510k needed if modifying to add bluetooth for data transmission?

    Hi, We have a cleared blood pressure monitor, and we intend to add a Bluetooth function to it (for data transmission) and we also develop a iOS APP for it (as to manage the data from the monitor). (1) I?m not sure whether should we submit a new 510k or not (after referring to the guidance...
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