Authors:
Valentine Casey
and
Fergal Mc Caffery
Affiliation:
Dundalk Institute of Technology, Ireland
Keyword(s):
Medical Device Software, Software Development, Software Process Assessment, Software Process Improvement, Medi SPICE, IEC 62304, ISO/IEC 15504-5, ISO 14971, ISO 13485, ISO/IEC 15504-2.
Related
Ontology
Subjects/Areas/Topics:
Model Evolution
;
Model Testing
;
Models
;
Paradigm Trends
;
Software Engineering
Abstract:
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 S
PICE model is provided.
(More)