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software (general topics)

  1. D

    Essential Requirements Checklist for Standalone Software

    For standalone software that is being run on a piece of hardware I was under the impression the hardware does not need to be considered with regard to the essential requirements checklist? I was under the impression the hardware will be CE marked in its own right and if I were to incorporate it...
  2. S

    How to make Single Sign On (SSO) Comply e-sig requirements?

    We have a training software that is part of multiple but independent software systems operating on Single Sign-On (SSO) access controls. In the training software, the trainee "reads and understands" the procedure. With the SSO in place, the trainee need not use his user name and password to...
  3. N

    Configuration Management - Physical Audit and Functional Audit for Software and Hardware

    Hi, I was wondering if I can bounce some ideas around to see if I'm on the right track with respect to Physical and functional audits (for Software and Hardware). From reading the ISO 10007 I understand that: A Functional configuration audit; is a formal examination to verify that a...
  4. Marcelo Antunes

    FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available

  5. I

    MDD Class I software technical documentation sample

    Hello, I have a question regarding technical documentation for MDD Class I software, specifically Device description. How detailed must be the individual parts of the device description such as general description, intended use ect. Are there any specific content requirements for each of these...
  6. L

    Traditional 510(K) - Software - Clinical testing?

    Hello Everyone, I am very new in FDA processes. I would like to submit a traditional 510k to our software (almost the same as syngo VD11). We already have a CE mark, so we have a ton of documents, sometimes I don't understand the differences between the two system. Electromagnetic...
  7. J

    KPI Software - Our weakness is in KPI's

    Hello, We are a new manufacturing company ( January 2018) however we are not new to the business, sold a previous machine shop couple years ago. Although are "home grown", learned what we needed at the time. We were ISO certified and knew how to pass the audits but did not work it or use it...
  8. V

    Software as control or protection will lead to different Software Safety Class?

    Hi, There are two design: 1. A control system is hardware and its protection system is software. Without software protection system, the control hardware failure will lead to serious harm. 2. A control system is software and its protection system is hardware. Without hardware protection system...
  9. brentg

    Software Class A - Lengthy further risk analysis

    Hi All I have been pruning info from this forum for some time now and am finally making the first post to see if any of you can help me out. We are a Class IIa Medical Device have been CE & FDA certified since 2013 plus we are ISO 9001 and 13485 certified. Our device is for providing...
  10. D

    Changing software classification via software - IEC 62304

    I have a question about the software classification as per clause 4.3 in edition 1.1. (2015 version) of 62304. In clause 4.3 the following statement is made: For a SOFTWARE SYSTEM initially classified as software safety class B or C, the MANUFACTURER may implement additional RISK CONTROL...
  11. K

    Trying to figure out what satisfies a few aspects of IEC 62304

    Hello, new to the forum here. My company is building a medical device and I was hired on to help establish the software verification and validation. My company does not have a lot of procedure in place so I've been trying to get a thorough understanding of what needs to be done to meet all...
  12. C

    Supplier Assessment for Hardware supporting SaMD

    Producing SaMD... what Supplier Assessments are needed for the hardware used in every day to test and develop the software? Is Supplier assessment needed of the hardware provider, or the reseller, other? Appreciate opinions.
  13. M

    ISO 14971 and Stand-Alone Diagnostic Software

    Hi all -- I am really struggling with a risk analysis. We make a stand-alone software device which is used to view echocardiograms. If, for some reason, the software fails and part of the echocardiogram is missing, a physician could potentially plan treatment with missing information. Or if...
  14. J

    Tracking-Calibration Software

    Hi, I know this subject been discuss over time.....BUT, questions seems to be for 'some' instruments....and answers keep coming back to 'cards - Excel - Access....' What I'm looking for, is a REAL Gauge Managing software With all the capabilities of back tracking for standard uses and all...
  15. L

    Re-calibrate after software update?

    WE have traditionally done software updates in the middle of the "as found" "as left" data collection, to ensure that the update didn't affect the ISO data. However, software updates were done on some other CMM's out side out this. Do we need to recalibrate (rerun the ISO data collection)...
  16. B

    Software for setting up New Warehouse

    Everyone, If there free or paid software out there that I can enter box dimensions, and avg monthly quantity along with my warehouse rack dimensions, and it will output a map to set up my FG's? We are looking for a more accurate, more adjustable FG warehouse, when at certain points of...
  17. P

    Is a different 510k is required for each (stand alone) software configurations?

    Does anyone know if a different 510k is required for each (stand alone)software configurations? For example, let's say this software is called "Anatool" for Windows and the version for MAC OS is called "AnatoolMAC". Both software has same functions and same intended use. Would I need to submit a...
  18. C

    Documenting Software Safety Classifications

    My company provides software engineering services to medical device manufacturers, and we have documented/tracked software safety classifications of software systems and items in different ways. I was wondering how others do it and what you think is best. Most of the time, we include the...
  19. K

    FDA Premarket Submissions for Embedded Software - Level of Concern

    Hello, I have been looking into the level of concern for a piece of embedded software under development. Question 4 of Table 1 of the FDA Premarket Submissions for Software guide, asks: Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury...
  20. Y

    Risk Control Implemented in Software

    Scratching my head over 60601-1, 14.6.2 (PEMS), Risk Control. For risk controls implemented in software, the standard says: Suitably validated tools and PROCEDURES shall be selected and identified to implement each RISK CONTROL measure. These tools and PROCEDURES shall be appropriate to...
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