1. V

    Firmware Verification Testing & Sample Size

    Hi All, We are developing custom firmware for our medical device (class II), and it is only intended to run on two versions of hardware. We are ISO 13485 and there is some leeway with statistical sample sizes/justification. I am struggling trying to understand if statistical sample size...
  2. D

    Documentation Requirements for Firmware in a 510(k) Submission

    I'm trying to determine the requirements for firmware incorporated into devices with respect to 510(k) documentation requirements. Is the software section of a 510(k) and the FDA software guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical...
  3. S

    PEMS Documentation for Medical Device Software - Requirements

    Hello, For one of our medical device we are having two software's, one is pc based software which is used to view the measurements and another which is the firmware for the device. My doubt is whether we need to follow PEMS documentation as per IEC 62304 for both the software for...
  4. T

    Firmware version in EMC report / DoC

    Dear Forum, do you know if the firmware version of a device under test needs to be documented in the EMC test report? My opinion is yes. Or is this only required for R&TTE? I have also seen a Declaration of Conformity mentioning the firmware. Under which conditions this is necessary? Thank you!
  5. C

    Is the firmware in a component OTS if it is customised?

    I am wrestling with the question of how to classify the firmware in a component used in a medical device. The component supplier sells the component generally, but has customised the firmware for interfacing to the medical device. The customisation is modification to the communication protocol...
  6. T

    Information and Structure for Technical Documentation for Firmware

    Could anyone provide template or draft which contain all necessary information and structure for firmware documentation? I'm little lost with creating dhf file for our new designed device. Device does not provide any automatic diagnose or analyze. Its Intended use as biofeedback device for...
  7. T

    Necessary test documents for Class II Medical Device Hardware and Firmware

    Hello All Cove members, I have struggled with next issues too long so now is time ask advice and tips. We notice in our internal audit that we havent finished uPSW (firmware) and HW test protocols for one of our device (Class II). We only discovered draft versions of documents. Type test plan...
  8. T

    510k Submission - Where to describe firmware and firmware design documentation?

    Hello, We are preparing a 510k submission for class IIa medical device. System contains pc-sw and sensor which is used acquisition of biosignals.System does not provide any automatic analysis or diagnoses. We have done all the documentation for pc-sw according to FDA guidance. But we are...
  9. S

    Medical Device Software (Firmware) Validation with using IEC62304

    Dear all, The firmware I 'm working on is developed using 62304. However, since 62304 does not cover software validation. I'm done with all the software verification activies, how should I handle the software validation? please help. thanks.
  10. P

    Introduction of SPC to the Supply Chain

    Long OP alert (probably 2 OP's) Good morning All, As I have mentioned in a couple of other posts we are starting to try and introduce SPC to our supply chain, and throughout our process. I am going to give an introduction to the project, and to the academic paper I am going to be writing...
  11. S

    Predicate Device Requirements - Firmware vs. Software Updates

    We have a cleared device. This device besides doing its primary function of measuring certain chemical in human bodily fluid also has some firmware which when plugged into PC allows data transfer, display, and report printing. We are adding additional features to the firmware side. Instead of...
  12. S

    What is the remedy if Unit level testing is not documented?

    Dear all, My company has been developing piece of firmware that was initially classified as Class A and then upgraded to Class B based on risk come out later on. Since class A software does not require Unit level testing, the test results were not documented. The project has been going on for...
  13. M

    Firmware Validation Protocol/template - FDA regulated Medical Devices industry

    I am working in a FDA regulated medical devices industry, we would like to validate our firmware version of our device. Can anyone please share the validation protocol/ template or model validation report samples
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