Applying ISO/IEC 29110 to ISO/IEC 62304 for Medical Device Software SME

Abstract

Medical Device (MD) and Medical Device Software (MDS) imperatively precise as they are dealing with human life and human health. Nowadays, medical device product manufactured by small and medium companies/entities/organization, which diverge from the past. To control the quality and security of those products, the Food and Drug Administration (FDA) regulation and IEC60601 are compulsory. Moreover, IEC60601 are referring to ISO/IEC 62304 on MDS development. The burden of small entities is an unawareness of the initiation point to adopting the ISO/IEC 62304 processes. This paper, we present a directive for a small entity who employed the ISO/IEC 29110 and aspire to apply the ISO/IEC 62304 processes. This is to prepare the small entity in planning to apply ISO/IEC 62304 before further testing and certification. Hence, the reviewed and aligned context of ISO/IEC 62304, ISO/IEC 29110, and ISO/IEC 12207 standards on the System Life Cycle processes are necessary.