SaMD also known as Software as a Medical Device is a term coined by International Medical Device Regulators Forum. The term SaMD means that a software built specifically for the use of many medical services can be used for many medical purposes. All this is done without using any hardware device.
A Software for a medical device is developed in order to give more accurate results without human error which were possible if done through hardware devices.
So if you are looking to make a software as a medical device then you should know that the software should follow certain guidelines set by SaMD regulators.
First of all, a software can be installed in any computer, laptop, tablet or even in mobile in the form of an mobile application. For ex, ECG is a machine used for heart tests. ECG machine comes up with all its equipments along with a software which can be installed in a computer or laptop.
How to See If a Software as a Medical Device is Good or Not?
If you want to make sure that a software as a medical device is good for use or not then it can be easily evaluated by keeping in mind the following conditions.
The conditions are:
- Valid Clinical Certification of a SaMD.
- Proper technical validation and certification of a SaMD.
Now you must be thinking that if you have completed these validations and certifications then how to see if your software is a medical device or not.
The above mentioned points are only the starting conditions which you need to fulfill in order to start the process.
Now, once done with the above mentioned criteria, you need to confirm if your product can be legally classified a software as a medical device or not.
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How to confirm?
Earlier it was difficult to determine if your product falls under the category of software as a medical device or not but now the path is quite easy.
As per MEDDEV 2.1/6, a software can be considered as a medical device only when it proves its forte as a benefit to a medical case or condition. If not then that software can’t be considered as a medical device.
How Software as a Medical Device are Classified under Different Categories?
As per MDD if a software wants to be considered as a medical device then it should prove itself to be useful for at least 1 active medical purpose.
The classification of a software as a medical device can be done by 3 ways and the ways are:
- Risk Factor.
- Number of Patients.
- Number of Users.
These are just points and if you want to read a full detailed version about how the classification is done then you can surely see rules 9, 10, 11 and 12 of annexure 9 of MDD.
Software as a Medical Device – A Boon or A Curse?
According to Orthogonal, software as a medical device is a boon but everything has its negative side as well. Here we will be discussing about the positive side of SaMD.
Think of a software which can be considered as a medical device which can even be installed in your mobile device and you can check your health status with your mobile phone only.
How cool that is right??
Software as a medical device has transformed the healthcare sector completely. It is all across the social media platforms, mobile phones, etc. It is proving to be a development which is changing the medical world. People can now purchase a software as per their particular medical need and then can consult a doctor. The doctor can do all the test and the results can now be feed in the software and this software will now be telling the patient about all the precautions and other updates including medicines to be taken, medicine time, diagnostics time, and other related information.
The review of software as a medical device includes a lot but this is just a brief article about it. More information will be coming up in our new updates.
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