Thank you to all viewers and likers of this video - much appreciated!! What would you like to know more about when working with medical device software? Please leave your suggestions below and remember to subscribe for upcoming videos!
But how do you get approved for IEC 62304. You have mentioned a few things that must be done regarding version control, documentation and etc. Do you have to provide the source code to whoever is issuing the certificates for them to analyze everything in order to confirm that you are fully compliant?
I would say that the single biggest challenge is that you have to show external reviewers evidence of your hard and good work. For example, it does not suffice to say: "I have tested the software." You also have to document how you did the test and what the results were. Many "newbies" underestimate the workload and end up re-creating software documentation afterwards. Usually, this is both painful and inefficient. My recommendation is to prepare yourself by studying the requirements of IEC 62304 to understand the expectations when developing medical device software fully. I know I am biased, but may I recommend this course: medicaldevicehq.com/introduction-to-software-for-medical-devices-and-iec62304-online-course/
@MedicalDeviceHQ Does the battery powered medical device need to comply this standard for the MCU firmware (baremetal and not OS) or its applicable to PC based software with OS?
Yes, any software including firmware developed for the purpose of being embedded in a medical device should comply with the standard. You find the following in the scope of IEC 62304: "This standard applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device."
@@christiankaestner6511 Thanks. Lets say a wearable ECG monitoring device which only collects ECG data and transfers it to a Mobile device(Phone/Tablet) where the Software displays the actual ECG waveform. In this case Mobile App must comply with 62304 however the Firmware of wearable device needs to be 62304 compliant?
@@bmistry5923 If the "wearable ECG monitoring device" is classified as a medical device, your firmware should be IEC 62304 compliant. IEC 62304 does not make a difference between software types.
@@christiankaestner6511 Thanks for the video! Related to the original question, where in the MDR can I find the requirement to follow this standard? My understanding is that it is not the IEC 62304 standard that requires its use, but only the MDR (per article 8 or 9). Yet, the list of harmonised standards (art. 8) published by the European Commission (ec.europa.eu/docsroom/documents/50115) does not include IEC 62304. Where can I find the requirement to follow this standard?
Thank you to all viewers and likers of this video - much appreciated!! What would you like to know more about when working with medical device software? Please leave your suggestions below and remember to subscribe for upcoming videos!
Hello i am a biomedical engineering student in india this video was helpful for me for my project work thank you 😊
That's great! Thank you for commenting!
But how do you get approved for IEC 62304. You have mentioned a few things that must be done regarding version control, documentation and etc. Do you have to provide the source code to whoever is issuing the certificates for them to analyze everything in order to confirm that you are fully compliant?
Thanks for the valuable content..
My pleasure!
Thank you very much sir!
Most welcome!
Please provide Quality Assurance Engineer roles and responsibilities in medical device
It depends. There is no formal definition for the role "Quality Assurance Engineer", therefore it is organisation dependent.
Very good and detailed Information
What are the challenges you will faceduring development of Software as a medical device? How ill you overcome the challenges?
I would say that the single biggest challenge is that you have to show external reviewers evidence of your hard and good work. For example, it does not suffice to say: "I have tested the software." You also have to document how you did the test and what the results were.
Many "newbies" underestimate the workload and end up re-creating software documentation afterwards. Usually, this is both painful and inefficient.
My recommendation is to prepare yourself by studying the requirements of IEC 62304 to understand the expectations when developing medical device software fully.
I know I am biased, but may I recommend this course:
medicaldevicehq.com/introduction-to-software-for-medical-devices-and-iec62304-online-course/
@MedicalDeviceHQ Does the battery powered medical device need to comply this standard for the MCU firmware (baremetal and not OS) or its applicable to PC based software with OS?
Yes, any software including firmware developed for the purpose of being embedded in a medical device should comply with the standard. You find the following in the scope of IEC 62304: "This standard applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device."
@@christiankaestner6511 Thanks. Lets say a wearable ECG monitoring device which only collects ECG data and transfers it to a Mobile device(Phone/Tablet) where the Software displays the actual ECG waveform. In this case Mobile App must comply with 62304 however the Firmware of wearable device needs to be 62304 compliant?
@@bmistry5923 If the "wearable ECG monitoring device" is classified as a medical device, your firmware should be IEC 62304 compliant. IEC 62304 does not make a difference between software types.
@@christiankaestner6511 Thanks for the video! Related to the original question, where in the MDR can I find the requirement to follow this standard? My understanding is that it is not the IEC 62304 standard that requires its use, but only the MDR (per article 8 or 9). Yet, the list of harmonised standards (art. 8) published by the European Commission (ec.europa.eu/docsroom/documents/50115) does not include IEC 62304. Where can I find the requirement to follow this standard?