IMDRF Proposes QMS Requirements For Software As A Medical Device
The International Medical Device Regulators Forum (IMDRF) has issued guidelines to help software developers better understand how quality management systems (QMS) already in place for conventional medical devices could apply to software intended for medical use.
The IMDRF distinguishes between the software embedded into medical device hardware and software designed to function on its own as a medical device (software as a medical device, or SaMD) and previously released a series of documents focused primarily on the latter.
These documents, one published in 2013 and another in 2014, sought to ease the growing SaMD industry into compliance with regulatory guidelines by defining SaMD specific terminology and suggesting categorization based on the seriousness of the disease the software was intended to treat.
In the 2013 document on terminology, the IMDRF said, “In general, existing regulations address public health risks of software when embedded in a traditional medical device. However, the current application of regulations and controls may not always translate or address the unique public health risks posed by SaMD nor assure an appropriate balance between patient/consumer protection and promotion of public health by facilitating innovation.”
In IMDRF’s latest guidelines, dated March 2015, the forum suggests that SaMD developers have a working knowledge of QMS systems currently in place. Because medical software can be accessed through a variety of platforms, the document also provides additional explanation on how existing regulations accommodate these products’ unique challenges.
The new document references ISO 13485:2003 and outlines the recommended infrastructure of QMS systems already familiar to medical device manufacturers. According to the IMDRF, all SaMD developers should have a scalable governance structure to provide support, organization, and accountability through all stages of the product’s lifecycle.
The document also addresses additional safety concerns that might be unique to medical software. These concerns include security risks, continuity risks from environmental interruption, and potential loss of software function due to upgrades in the device’s underlying operating system.
SaMD developers should consider the many different devices (laptops, smartphones, tablets, etc.) that could access the software and their respective suitability. Also, the limitations or disabilities of potential users could affect the software’s performance or safety and should be taken into account.
The IMDRF was founded in 2011 following the dissolution of the Global Harmonization Task Force on Medical Devices, and is composed of a voluntary group of medical device regulators who seek to “accelerate international medical device regulatory harmonization and convergence.”