Ins and Outs of software as a medical device – #BHHMembersInitiatives

BHH member ERNI launched an eBook where they elobaroate about the ins and outs of software as a medical device. They provide the key technology and regulatory aspects to consider in MDSW life cycle management.

Digital health technologies are being developed into many kinds of applications that are already changing therapeutic and diagnostic approaches to disease management and will certainly dramatically change medicine in the coming years. This includes software platforms that enable better doctor-to-patient communication and clinical history records management tools, software modules that drive medical electric instruments and stand-alone software solutions that process medical information against big data stored in the cloud, etc.

Algorithms can automate the analysis of large datasets, speeding up patient management decisions. Software technologies can combine input data of different natures and unveil clinically relevant information. Software, in short, has enormous potential in health management and it is crucial that digital health application developers understand the underlying regulatory framework that both their organisations and these appliances need to comply with for the legal placing on the EU market.

The intent of this eBook is to give an overview about the guidelines of developing medical device software, which in Europe is a particular software category that is governed by either Regulation EU/2017/745 on medical devices (MDR), or Regulation EU/2017/746 on in vitro diagnostic medical devices (IVDR).

The content shared in this document is based on Regulation EU/2017/745 on medical devices (MDR), Regulation EU/2017/746, IEC62304:2006 as well as ISO13485:2016 and ISO14971:2019; and summarises a framework of life cycle processes with activities and tasks required to fulfil for the safe design of medical device software.

Interested? Download the eBook here.