2 research outputs found
Medi SPICE and the development of a process reference model for inclusion in IEC 62304
The demand for medical device software continues to grow and there is an associated
increase in its importance and complexity. This paper discusses medical device software process
assessment and improvement. It outlines Medi SPICE, a software process assessment and
improvement model which is being developed to meet the specific safety-critical and regulatory
requirements of the medical device domain. It also details the development of a subset of the Medi
SPICE process reference model for inclusion in the next release of the IEC 62304 standard: Medical
device software - Software life cycle processes. IEC 62304 is a key standard for medical device
software development and is approved by many national regulatory bodies including the Food and
Drug Administration in the United States and the European Union. This paper also outlines 3
lightweight software process assessment methods which have been developed in tandem with Medi
SPICE. Finally the timeline for the release of the full Medi SPICE model is provided