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How to handle Software/Firmware to be MDR compliant?

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Guest user Created:   Jan 21, 2022 Last commented:   Jan 22, 2022

How to handle Software/Firmware to be MDR compliant?

I just listened to your webinar about EU MDR. It was quite rewarding as there were few surprices but still some good information. I have a more specific question regarding software. Background: We have a unit that cuts out a form in styrofoam which is then filled with a low melting point alloy. This hardend form is the put between the patient and the source of radiation to limit the radiation to certain places. The unit itself has the technical documentation made. However there are two aspects which I am uncertain how to handle: 1) Software. There is a computer software that receives input from user (from xray etc) and then converts the desired shape to be cut. 2) Firmware. The unit itself has a firmware implmented that receives the data from above software and performs the actual control of the unit. My question is: How are these two to be handled in the technical documentation? Most of the standard sections do not apply to software (Biocompatibility to name one). So.. how to handle Software / Firmware to be MDR compliant .
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jan 22, 2022

Yes, you are right that Biocompatibility does not apply to the software. But other documents are applicable with some adjustments.

First what you need is to go to Annex I; - General safety and performance requirements and to see which of those requirements are applicable for you. 

Then, I suggest going to the following MDCG guidance that are specific for software as a medical device:

Also, be aware that medical device software must be in compliance with the following standard: IEC 62304:2006 - MEDICAL DEVICE SOFTWARE — SOFTWARE LIFE CYCLE PROCESSES

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