Use Arduino Mini 05 board in our future medical device

Hello guys,

We are in the process of developing a medical device for the US market that is intended for preterm infants. One of the units within a device will be controlled with the Arduino Mino 05 board. At least this is our intention.

The product will need to pass numerous certification procedures (FDA, IEN, ISO...).

I would like to know can we use the original Arduino Mini 05 board as is (just plug it in appropriate header and let it control the unit) or it will be better for us to use just a processor from the Mini board (ATmega328P) and solder it on our custom PCB ? I mean, is Arduino Mini 05 board certified and ready to be used in other projects as a certified control unit?

Thanks in advance for your time and effort.

Sincerely, Bojan.


Thanks for the info, buddy.

Let me give you some more info about the part that will hopefully be driven by Atmega328P. This is the sub-system of the medical device that will, when in use, be detached from the main unit and taken away. The function of the Atmega328 driven sub-system would be to discharge the wastewater tank with the help of sensor level switches as well as the discharge pump. The patient (the baby) will not be in any kind of contact with this sub-system neither the sub-system will anyhow impact the patient.

I can understand that it is not allowed to use Arduino Mini 05 board as the local control unit. I wonder though why it will be impossible to use an original ATMEGA328P soldered it on my custom PCB to control the discharge process for me!?

If it turns it is impossible to use Atmega32p, can you give me the model of some similar micro-controlled that is appropriate for the use?

Thanks for the clarification.

Sincerely, Bojan.


Well, this post here on the forum is the part of my research. I was thinking to start here and try to get the info from the first hand - from the designers that already have the experience in the field.

I don't want you to do research for me.

Thanks for your time.

P.S. I'm sorry, girl, if I offended you.

I spent over 15 years in the Medical Device field writing control software for medical instruments and as a result had to be trained & certified annually in Good Manufacturing Practice and Quality Procedures.

Yes, you could use an Arduino in a Medical Device, but I have no idea why you would want to. Since you do not have control over the Arduino's Design History, then, per FDA regulations you will have to do 100% validation testing on all the units. If you designed and built them yourself, then you could validate the design and the manufacturing process ONCE and then you only need to do final tests on the end product after manufacturing them using the validated process. Either way, the cost of doing this will vastly overshadow any minor cost benefit of buying an Arduino.

You can use an AVR, etc. chip in your device. It does not have to be "certificated" for the application. You, as the device manufacturer, are taking on that responsibility of validating that it is appropriate for the intended use. If the chip has to have a certain parameter meet a specific requirement, then you'd work with the manufacturer to be sure that all the chips you buy have that. You need to manage your supply chain, which is just not happening if you're buying Arduinos on eBay!

Sorry, but if you're at a point where you're asking such basic Quality Management questions, I strongly suggest you hire a consultant ASAP.

PM me if you need a bit of guidance. I'm no expert consultant, but at least I have experience in the field.