Does your medical device have a software component?

Is there a need to address software in your regulatory submission?

  • Authored by: Mark DuVal
  • Published on: September 26, 2018
Software or an application can be a part of a medical device

Executive summary

Many medical products today have a software component. Sometimes software is the single largest component in the design of the product – other times it is a very small part. Sometimes software is not part of the design at all. But does this mean that software can be ignored?

What if you are creating a product that does not contain software at all, or a product that incorporates another piece of equipment that comes with fully developed and validated software. Is there any need to address software in your regulatory submission for a product such as this? The answer is Yes!

When to consider software components

When developing medical products, regulatory concerns for software should be considered even when the product does not contain software itself. Risks related to software can come from outside as well as from within, and this should be evaluated and considered to have a smooth submission for your design.

Involving a software consultant during the early phases of a product development project can help to identify software related risks...

To illustrate this, envision a product that is completely hardware based, but contains some memory for data storage by an outside device. While this product does not contain any software itself, it could be used by other products or parts of the system that do. For this case you would still need to do a risk analysis to determine hazards that could occur with misuse or malicious use of your product. One example of risk could be that a third party device uses the internal storage available on your device to covertly store a virus that can be transmitted to a third device when it is connected at a later date. Possible hazards could be that this virus collects patient information and reveals it to unauthorized parties. Or the virus could be even more malicious and damage parts of other systems, or compromise safety. Has your system been designed to protect against this?

Involving a software consultant during the early phases of a product development project can help to identify software related risks. Additionally, a good consultant can help to identify and produce deliverables that will be required for a submission that might otherwise be overlooked, helping to smooth the review process.


Most projects to develop a medical product should look to see if there is a need to address software or software related impact, even if no software is used within the product itself. In most of these cases the task can be as simple as performing a risk analysis that demonstrates there is no risk, or that risk can be mitigated down to an acceptable level. In other cases, you may discover an unanticipated hazard that requires consideration within the products design to mitigate properly.

We can help you assess your risks to make sure your submission goes as smoothly as possible!

The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM