Software Validation Documentation for Medical Devices - FDA eSTAR
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- เผยแพร่เมื่อ 27 ก.ย. 2024
- This video shows you how to use SYS-044, our software validation procedure and associated templates to document your software validation for a medical device (i.e., SaMD, SiMD, or Firmware). The video also shows you where to attach these documents in the new FDA eSTAR v5.1 for 510(k) and De Novo submissions.
The video includes novel diagrams showing when various documents are created in the software development process.
Links:
SYS-044 - www.medicaldev...
WI-007 - www.medicaldev...
What is IEC 62304? - • What is IEC 62304?
What is IEC TR 80002-1:2009 - • What is IEC TIR 80002-...
There is a newer Off-the-Shelf Sofware Use in Medical Devices Guidance that was issued in August 2023.
Thank you. You are correct. Here's the link: www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices
RE application development, I think you meant agile. Includes things like Scrum, Kanban, etc.
If only you had been on the live session and unmuted your microphone...That exactly the word I couldn't remember.
This is hands downs the best training I’ve received on software documentation for eStar. Thank you and please keep the great tutorials coming.
Wow, thank you! There are 26 other videos on the eSTAR available as part of our 510(k) course: medicaldeviceacademy.com/510k-course/
Is the calibration applicable to a samd??
If applicable pls suggest me the guidance document
In general, no. Software is not generally a measuring device, and therefore it is not subject to the calibration requirement. However, you can have software that has a measurement function. For example, if the software allows you to display and measure x-ray or CT images, then you need to compare the accuracy of manual measurements performed by a radiologist or radiology technician with measurements made with the software. In this case, the accuracy of the measurements is validated. At the same time, there is no physical calibration performed. Physical calibration is performed on the imaging equipment--typically using a phantom. There are also DICOM imaging standards that apply to most imaging software, but it depends on the modality of imaging.
In another example, ECG software, the software is validated against a library of ECG data of known heart rhythms. The software must be able to detect and identify specific signals in the validation database. There are standards for this validation of the software, but there is no physical calibration performed.
If you have an optical measuring device, you might verify that accuracy of the optical measurements using a calibrated grid. In this case, you would use the grid as your NIST traceable standard and you would verify calibration of the system prior to use. In this case the accessory is calibrated--not the software. The system can be altered by changing optics or other adjustments, but when you verify the system is calibrated with the grid it will identify the optics or other adjustments were made.
Therefore, calibration will apply to the system and may be used as part of validation of the system. In this case, it is really SiMD--not SaMD. But if your company develops software that is used with a device, your SaMD might be part of a device system that requires calibration.
@@MedicalDeviceAcademyMany thanks for swift response and wonderful explanation
Is the shelf life applicable to a stand alone software device??
No. Shelf-life would not be applicable to SaMD. It is applicable to SiMD (e.g., devices with batteries, capacitors, electrodes). I discussed this specific issue in the shelf-life webinar I taught earlier today:
medicaldeviceacademy.com/shelf-life-webinar/
@@MedicalDeviceAcademy wow many thanks, really appreciated