Global Perspective on Software as a Medical Device (SAMD): Development Process, Associated Risks, and Legislative Aspects

Abstract

Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital platforms for both medical and non-medical uses. One of three forms of software connected to medical devices is software that, on its own, qualifies as a medical device. This article intends to provide an analysis and summary of recent research in the field of medical device development methodology, explore these investigations’ phases, and assess the risk and legal implications. The literature search was carried out to find peer-reviewed articles on content released between 2010 and 2021 in Scopus, Web of Science, and Science Direct. based on criteria for inclusion and exclusion. Given the distinctive characteristics of software as a medical device (SaMD) that go beyond those of conventional medical hardware or devices, regulators across the globe started to realize the need to consent to a framework and set of guiding principles for the industry. This will allow all stakeholders, including regulated entities, to advance safe innovation and safeguard patient safety. From the time a product is first conceptualized until it is launched onto the market, the development of software as a medical device is incredibly complicated and greatly relies on the use of good manufacturing practices. The key issues that must be addressed in the future are the transparency of regulatory processes throughout the globe.

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